PMA P020056S048
- Device
- NATRELLE Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S048
- Product code
- FTR
- Decision date
- 2018-08-01
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Replace paper chart recorders and to use an electric heating module rather than water to heat the air in the carousel room.
Current openFDA PMA Record#
- Device
- NATRELLE Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S048
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2018-08-01
- Decision code
- OK30
- Date received
- 2018-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace paper chart recorders and to use an electric heating module rather than water to heat the air in the carousel room.