PMA P070004S007
- Device
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S007
- Product code
- FTR
- Decision date
- 2014-01-08
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGES TO THE MATERIAL OF THE BREAST IMPLANT MOLDS.
Current openFDA PMA Record#
- Device
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P070004
- Supplement
- S007
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-01-08
- Decision code
- OK30
- Date received
- 2013-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE MATERIAL OF THE BREAST IMPLANT MOLDS.