PMA P070004S015
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S015
- Product code
- FTR
- Decision date
- 2019-04-17
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for new round implant styles 10621-XP, 10721-XP, 20621- XP, and 20721-XP.
Current openFDA PMA Record#
- Device
- Sientra OPUS Silicone Gel Breast Implants
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S015
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2019-04-17
- Decision code
- APPR
- Date received
- 2019-01-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new round implant styles 10621-XP, 10721-XP, 20621- XP, and 20721-XP.