Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016823837

FEI Number

3016823837

Entity Name

LIFECELL CORP

City/State/Country

Branchburg, NJ, US

Establishment Address

4 Millenium Way, Branchburg, NJ 08876, US

Establishment Type(s)

Manufacture Medical 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

BK220721

PMA Number

N/A

All Registered Proprietary Names

NovoMatrix Reconstructive Tissue Matrix Strattice Reconstructive Tissue Matrix (RTM) Perforated Strattice Reconstructive Tissue Matrix (RTM) Laparoscopic Strattice Reconstructive Tissue Matrix (RTM); Strattice Reconstructive Tissue Matrix Extra Thick REVOLVE ENVI 600 Advanced Adipose System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2019-07-02
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2017-05-30
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
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2017-05-30
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2023-05-16

Official Correspondent

James Wabby

US Agent Details

No US Agent registered (Local establishment).

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
3013307971	ABBVIE Logistics BV, Inc	Zwolle Overijssel, NL
8020862	ALLERGAN PHARMACEUTICALS IRELAND	WESTPORT Mayo, IE
3005113652	ALLERGAN	Annecy Haute-Savoie, FR
1647098	LIFECELL CORP.	BRANCHBURG, NJ, US

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.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016823837. Last updated year: 2026. Please use registration number 3016823837 when referencing this establishment in official correspondence.