Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615742

FEI Number

3003521774

Entity Name

SOFRADIM PRODUCTION

City/State/Country

TREVOUX Auvergne-Rhone-Alpes, FR

Establishment Address

116 AVENUE DU FORMANS, TREVOUX Auvergne-Rhone-Alpes 01600, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250869

PMA Number

N/A

All Registered Proprietary Names

Parietex 2D 3D Anatomical Mesh Symbotex Composite Mesh Progrip Self-Gripping Polyester Mesh Versatex Monofilament Mesh ProGrip Self-Gripping Polypropylene Mesh Symbotex Composite Mesh Progrip self-gripping polypropylene mesh Versatex Monofilament Mesh Parietene DS Composite Mesh Dextile Anatomical Mesh Permacol Surgical Implant US Permacol Surgical Implant US Parietex Plug and Patch System ProGrip Self-Gripping Polyester Mesh ProGrip Laparoscopic Self-Fixating Mesh ParieteneTM Macroporous Mesh Parietex 2D 3D Anatomical Mesh ENDURAGen Collagen Implant Permacol Surgical Implant US Parietex Composite Ventral Patch Transorb Self-Gripping Resorbable Mesh ProGrip advanced self-gripping polypropylene mesh Parietene Flat Sheet Mesh Parietene Macroporous Mesh ProGrip Laparoscopic Self-Fixating Mesh Parietene Macroporous Mesh

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-06-29
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-01-21
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2018-02-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-02-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-01-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-02-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2017-07-12
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-11-03
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2014-05-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2014-05-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-02-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-12-13
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-10-14
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2014-05-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2012-12-11
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2012-12-11
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-02-14
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2024-02-14
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2024-02-14
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2026-05-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-11-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-02-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-02-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-04-29

Official Correspondent

No official correspondent registered.

US Agent Details

Marsha Seetaram Business: Covidien LLC Email: marsha.n.seetaram@medtronic.com Phone: (904) 2812763

Related Public Records

Same Entity

Covidien llc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615742. Last updated year: 2026. Please use registration number 9615742 when referencing this establishment in official correspondence.