PMA P040046S014
- Device
- NATRELLE HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S014
- Product code
- FTR
- Decision date
- 2016-08-25
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for removal of the DSMB from the BIFS-001 study protocol.
Current openFDA PMA Record#
- Device
- NATRELLE HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S014
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-08-25
- Decision code
- APPR
- Date received
- 2015-12-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for removal of the DSMB from the BIFS-001 study protocol.