- Device
- NATRELLE Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S046
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2021-06-25
- Decision code
- OK30
- Date received
- 2021-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to implement an Electronic Data Acquisition (EDA) System to record and store the cycle parameters of the dry heat sterilization process used in the manufacture of Allergan Natrelle® Saline-Filled Breast Implants and Allergan Natrelle® Silicone-Filled Breast Implants