PMA P020056S049
- Device
- Natrelle Silicone Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S049
- Product code
- FTR
- Decision date
- 2019-06-27
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Implementing changes to the gel filling process, specifically, changing from manual filling to an automated process.
Current openFDA PMA Record#
- Device
- Natrelle Silicone Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S049
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2019-06-27
- Decision code
- OK30
- Date received
- 2019-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementing changes to the gel filling process, specifically, changing from manual filling to an automated process.