Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617229

FEI Number

3006108784

Entity Name

ALLERGAN

City/State/Country

LA AURORA DE HEREDIA, CR

Establishment Address

900 PARKWAY GLOBAL PARK, LA AURORA DE HEREDIA 191-3006, CR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants: FF,FM,FL,MF,MM, ML,LF,LM,LL,FX,MX,LX Natrelle 133 Tissue Expander Natrelle 133 Tissue Expander No Suture Tabs: 133 FV, 133 FX, 133 MV, 133 MX, 133 SX, 133 SV, 133 LV Natrelle 133 Plus Tissue Expander Natrelle 133 Plus Tissue Expander - 133P FV, 133P FX, 133P MV, 133P MX, 133P SX, 133P SV, 133P LV CUI Versafil Tissue Expanders Natrelle Saline-Filled Breast Implants: 10, 15, 20, 40, 45, 110, 115, 120 Natrelle Inspira Breast Implants: SRL, SRLP, SRM, SRF, SRX, TRF, TRL, TRLP, TRM, TRX, SSF, SSM, SSL, SSLP, SSX Natrelle Inspira Cohesive Breast Implants: SCF, SCL, SCLP, SCM, SCX, TCF, TCL, TCLP, TCM, TCX Natrelle Saline-Filled Breast Implants Natrelle Saline-Filled Breast Implants - 68MP, 68HP, 68LP, 363LF, 163, 168, 468 Natrelle 133 Tissue Expander - Suture Tabs: 133 FV-T, 133 FX-T, 133 MV-T, 133 MX-T, 133 SV-T, 133 SX-T, 133 LV-T Natrelle 133 Tissue Expander with Suture Tabs NATRELLE INSPIRA Single Use Sizers for Gel Implants Insertion Sleeve; Keller Funnel; Keller Funnel 2 Fill Tube Kit Safsite Injection Site Reflux Valve Natrelle 133S Tissue Expander Styles: S-FV, S-FX, S-MV, S-MX, S-SX, S-SV Natrelle 133S Tissue Expander Styles: 133S FV-T, 133S FX-T, 133S MV-T, 133S MX-T, 133S SV-T, 133S SX-T, 133S LV-T MagnaFinder Xact Infusion Set, Universal Fill Kit, Winged Infusion Set Style 133 Series Templates

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	Class 3	878.3540	2014-12-19
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2014-12-19
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2015-08-24
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2014-12-19
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	Class 3	878.3540	2014-12-19
FWM	Prosthesis, Breast, Inflatable, Internal, Saline	General, Plastic Surgery	Class 3	878.3530	2014-12-19
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2014-12-19
MRD	Mammary Sizer	Unknown	Class U	N/A	2021-11-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-01-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-03-08
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2019-02-27
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2018-03-08
HWT	Template	Orthopedic	Class 1	888.4800	2015-01-23

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
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
K161483	Stradis Healthcare	Unger Quad Injector	2016-10-31
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-04	N/A	3	McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

Registration Number	Establishment Name	Location
3016050935	TIGER AESTHETICS MEDICAL-57	Franklin, WI, US
3012883202	ESTABLISHMENT LABS S.A.	Coyol Alajuela, CR
3010531069	PRO-TECH Design & Mfg, Inc.	Arlington, TX, US
2011068	ALLERGAN SALES, LLC	IRVINE, CA, US
1645337	MENTOR	IRVING, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617229. Last updated year: 2026. Please use registration number 9617229 when referencing this establishment in official correspondence.