NATRELLE SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990074/S024 · decided 2012-07-23
Approval details
- PMA number
- P990074
- Supplement
- S024
- 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
- 2012-05-30
- Decision date
- 2012-07-23
- Days to decision
- 54 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDITION OF A STEP TO THE INCOMING INSPECTION PROCEDURES FOR THE RAW MATERIALS USED IN THE MANUFACTURE OF THE DEVICE.
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510(k) clearances by this applicant
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| NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229) | Allergan | 2021-06-02 |
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| 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 |