NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
FDA premarket approval P040046/S003 · decided 2013-06-20
Approval details
- PMA number
- P040046
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Allergan
- Date received
- 2013-05-22
- Decision date
- 2013-06-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDITIONAL DRY HEAT STERILIZERS FOR PROCESSING SILICONE-FILLED BREAST IMPLANTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |