PMA P040046
- Device
- NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S032
- Product code
- FTR
- Decision date
- 2021-07-26
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S031
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2021-07-26
- Decision code
- APPR
- Date received
- 2020-06-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.