- Device
- NATRELLE Style 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P040046
- Supplement
- S032
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2020-07-30
- Decision code
- OK30
- Date received
- 2020-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative detection method for the Quality Control bacterial endotoxin testing of the finished devices.