PMA P990074S054
- Device
- NATRELLE Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S054
- Product code
- FWM
- Decision date
- 2024-12-16
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- changes to the adhesive coating that is used to secure the lids to the thermoformed trays
Current openFDA PMA Record#
- Device
- NATRELLE Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S054
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2024-12-16
- Decision code
- OK30
- Date received
- 2024-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the adhesive coating that is used to secure the lids to the thermoformed trays