SIENTRA SILICONE GEL BREAST IMPLANTS
FDA premarket approval P070004/S006 · decided 2013-12-18
Approval details
- PMA number
- P070004
- Supplement
- S006
- 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
- 2013-09-19
- Decision date
- 2013-12-18
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- APPROVAL FOR ADDITIONAL IMPLANT STYLES THAT INCORPORATE CHANGES TO THE APPROVED PMA DEVICES AND INCLUDES THE FOLLOWING STYLES: 10610-LP; 10621-MP/HP; 10712-MP; 10722-HP; 20710-LP; 10710-LP; 20721-MP/HP; 10721-MP/HP; FIVE ADDITIONAL SIZES OF THE 10512-MP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 10521-HP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 20610-LP STYLE IMPLANT; AND EIGHT ADDITIONAL SIZES OF THE 20621-MP/HP STYLE IMPLANT.
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