MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468
FDA premarket approval P990074/S009 · decided 2001-09-21
Approval details
- PMA number
- P990074
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2001-08-31
- Decision date
- 2001-09-21
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO ADD MECHANICAL TESTING OF SAMPLE SHELLS PRODUCED AS PART OF THE INCOMING INSPECTION PROCESS FOR THE RTV SILICONE DISPERSION. THIS TESTING SERVES AS AN ADDITIONAL CRITERION FOR THE ACCEPTANCE OF THE RAW MATERIAL USED TO MAKE ALL STYLES OF THE SALINE-FILLED BREAST IMPLANTS.
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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 |