Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013307971

FEI Number

3013307971

Entity Name

ABBVIE Logistics BV, Inc

City/State/Country

Zwolle Overijssel, NL

Establishment Address

Zuiderzeelaan 53, Zwolle Overijssel 8017 JV, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

AbbVie, Inc. (Owner Number: 2011068)

Owner / Operator Contact Address

2525 DUPONT DRIVE, --, Irvine, CA 92612, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130817

PMA Number

N/A

All Registered Proprietary Names

Strattice Reconstructive Tissue Matrix (RTM) Laparoscopic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2017-05-30
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2017-05-30

Official Correspondent

James Wabby

US Agent Details

James Wabby Business: ABBVIE, INC. Email: james.wabby@abbvie.com Phone: (714) 2462259

Related Public Records

Same Entity

AbbVie, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1643525	ALLERGAN SALES, LLC	WACO, TX, US
8020862	ALLERGAN PHARMACEUTICALS IRELAND	WESTPORT Mayo, IE
3005113652	ALLERGAN	Annecy Haute-Savoie, FR
1647098	LIFECELL CORP.	BRANCHBURG, NJ, US
9617229	ALLERGAN	LA AURORA DE HEREDIA, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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 3013307971. Last updated year: 2026. Please use registration number 3013307971 when referencing this establishment in official correspondence.