PMA P990074S044
- Device
- NATRELLE Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S044
- Product code
- FWM
- Decision date
- 2020-07-30
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Addition of an alternative detection method for the Quality Control bacterial endotoxin testing of the finished devices.
Current openFDA PMA Record#
- Device
- NATRELLE Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S044
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- 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.