PMA P020056S053
- Device
- NATRELLE Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S053
- Product code
- FTR
- Decision date
- 2021-04-10
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Addition of new ovens used in the manufacturing process of NATRELLE Silicone-Filled Breast Implants.
Current openFDA PMA Record#
- Device
- NATRELLE Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S053
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2021-04-10
- Decision code
- OK30
- Date received
- 2021-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new ovens used in the manufacturing process of NATRELLE Silicone-Filled Breast Implants.