Data / Medical devices / Costa Rica / Allergan
Allergan: FDA-registered device maker in La Aurora De Heredia, Costa Rica, 10 510(k) clearances and 3 PMA approvals
Allergan is registered with the FDA (registration 9617229) in La Aurora De Heredia, Costa Rica. It lists 9 device types. The FDA files 10 510(k) clearances and 3 PMA approvals under its listings, the newest dated September 12, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617229
- FEI number
- 3006108784
- Address
- 900 Parkway Global Park, La Aurora De Heredia, Costa Rica, 191-3006
- Owner or operator
- AbbVie, Inc. (2011068)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 19, 2014
- Registered through
- 2027
- Brand names listed
- CUI Versafil Tissue Expanders, CoolSculpting Elite System, DPRO, EnDoucer Dermolissage, Fill Tube Kit, Infusion Set, Universal Fill Kit, Winged Infusion Set, Insertion Sleeve; Keller Funnel; Keller Funnel 2, MagnaFinder Xact and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Dermal Cooling Pack/Vacuum/Massager | OOK | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mammary Sizer | MRD | U | Manufacturer | accessdata.fda.gov |
| Prosthesis, Breast, Inflatable, Internal, Saline | FWM | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | 3 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | accessdata.fda.gov |
| Tissue Expander And Accessories | LCJ | U | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2024 | K233732 | CoolSculpting Elite System | OOK | Substantially Equivalent | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | accessdata.fda.gov |
| June 2, 2021 | K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | MRD | Substantially Equivalent | Allergan | accessdata.fda.gov |
| August 29, 2018 | K182054 | Natrelle 133S Tissue Expander | LCJ | Substantially Equivalent | Allergan | accessdata.fda.gov |
| August 20, 2015 | K143354 | Natrelle 133 Plus Tissue Expander | LCJ | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| January 5, 2011 | K102806 | NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS | LCJ | Substantially Equivalent | Allergan Medical | accessdata.fda.gov |
| July 14, 1995 | K942988 | FILTERED EXTENSION SETS | FPA | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| May 22, 1987 | K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | LCJ | Substantially Equivalent | Cox-Uphuff Intl. | accessdata.fda.gov |
| July 23, 1986 | K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | LCJ | Substantially Equivalent | Mcghan Medical Corp. | accessdata.fda.gov |
| September 18, 1985 | K853014 | MCGHAN TISSUE EXPANDER FILL KIT | LCJ | Substantially Equivalent | Mcghan Medical Corp. | accessdata.fda.gov |
| August 12, 1983 | K831566 | CUI MAMMARY PROTHESIS SIZER | MRD | Substantially Equivalent | Cox-Uphuff Intl. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 20, 2013 | P040046 | NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS | FTR | 29 | July 26, 2021 | accessdata.fda.gov |
| November 17, 2006 | P020056 | NATRELLE SILICONE-FILLED BREAST IMPLANTS | FTR | 56 | September 29, 2026 | accessdata.fda.gov |
| May 10, 2000 | P990074 | NATRELLE SALINE BREAST IMPLANTS | FWM | 52 | December 16, 2024 | accessdata.fda.gov |
Compare with other makers
- All makers of Template
- All makers of Tissue Expander And Accessories
- All makers of Brush, Dermabrasion, Powered
- All makers of Prosthesis, Breast, Inflatable, Internal, Saline
- All makers of Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- All makers of Dermal Cooling Pack/Vacuum/Massager
Updated September 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.