PMA P070004S001
- Device
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S001
- Product code
- FTR
- Decision date
- 2012-05-29
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S001
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2012-05-29
- Decision code
- APPR
- Date received
- 2012-03-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.