PMA P020056S018
- Device
- NATRELLE SILICONE-FILLED BREST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S018
- Product code
- FTR
- Decision date
- 2015-03-05
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- APPROVAL FOR UPDATED LABELING TO INCLUDE 10 YEAR DATA FROM THE CORE CLINICAL STUDY.
Current openFDA PMA Record#
- Device
- NATRELLE SILICONE-FILLED BREST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S018
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2015-03-05
- Decision code
- APPR
- Date received
- 2012-12-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATED LABELING TO INCLUDE 10 YEAR DATA FROM THE CORE CLINICAL STUDY.