PMA P070004S042
- Device
- Sientra Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- Product code
- FTR
- Decision date
- 2024-02-01
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- for a stand-alone Statistical Analysis Plan (SAP) for Sientras US Post Approval Study (US-PAS)
Current openFDA PMA Record
- Device
- Sientra Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S042
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2024-02-01
- Decision code
- APPR
- Date received
- 2024-01-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- for a stand-alone Statistical Analysis Plan (SAP) for Sientras US Post Approval Study (US-PAS)