PMA P020056S024
- Device
- NATRELLE SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S024
- Product code
- FTR
- Decision date
- 2014-02-14
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD.
Current openFDA PMA Record#
- Device
- NATRELLE SILICONE-FILLED BREAST IMPLANTS
- Applicant
- Allergan
- PMA number
- P020056
- Supplement
- S024
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2014-02-14
- Decision code
- OK30
- Date received
- 2014-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD.