PMA P070004S006
- Device
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S006
- Product code
- FTR
- Decision date
- 2013-12-18
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order 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.
Current openFDA PMA Record#
- Device
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S006
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2013-12-18
- Decision code
- APPR
- Date received
- 2013-09-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.