NATRELLE SALINE BREAST IMPLANTS
FDA premarket approval P990074/S033 · decided 2016-10-07
Approval details
- PMA number
- P990074
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NATRELLE SALINE BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2016-09-07
- Decision date
- 2016-10-07
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.
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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 |