SIENTRA SILICONE GEL BREAST IMPLANTS
FDA premarket approval P070004/S008 · decided 2016-12-02
Approval details
- PMA number
- P070004
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2015-03-23
- Decision date
- 2016-12-02
- Days to decision
- 620 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for new implant styles 20512-MP, 20712-MP, 20646-RB (MP), and 20676-E (HP); and additional sizes of the following styles: 10621-HP, 10721-HP, 20621-HP, 20721-HP, 20645-LP, 20645-MP, 20645-HP, 20646-RB (HP), and 20646-RB (MP).
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