NATRELLE SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990074/S023 · decided 2013-09-10
Approval details
- PMA number
- P990074
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NATRELLE SALINE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2011-01-24
- Decision date
- 2013-09-10
- Days to decision
- 960 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR PHYSICIAN AND PATIENT LABELING REVISIONS TO INCLUDE INFORMATION ABOUT ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) AND CONNECTIVE TISSUE DISEASE (CTD) RISKS WITH THE NATRELLE® SALINE-FILLED BREAST IMPLANT.
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 |