PMA P020056
- Device
- Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S059
- Product code
- FTR
- Decision date
- 2026-09-29
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- approval for revised labeling to include the results of the BIFS Arm study.
Current openFDA PMA Record#
- Device
- Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S064
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2026-09-29
- Decision code
- APPR
- Date received
- 2024-09-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for revised labeling to include the results of the BIFS Arm study.