NATRELLE SILICONE-FILLED BREAST IMPLANTS
FDA premarket approval P020056/S020 · decided 2013-06-12
Approval details
- PMA number
- P020056
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NATRELLE SILICONE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Allergan
- Date received
- 2013-05-20
- Decision date
- 2013-06-12
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229) | Allergan | 2021-06-02 |
| TrueTear Intranasal Tear Neurostimulator (K193589) | Allergan | 2020-08-31 |
| Natrelle 133 Plus MICROCELL Tissue Expander (K180826) | Allergan | 2018-12-21 |
| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
| SERI SURGICAL SCAFFOLD (K123128) | Allergan | 2013-04-25 |