Natrelle Saline-Filled Breast Implants
FDA premarket approval P990074/S041 · decided 2017-11-03
Approval details
- PMA number
- P990074
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Natrelle Saline-Filled Breast Implants
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2017-10-02
- Decision date
- 2017-11-03
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Implement an Electronic Data Acquisition (EDA) System to collect cycle parameter, such as temperature and time, for the shell drying after washing and gel curing after shell filling occur in the Blue-M oven. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.
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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 |