PMA P990074S050
- Device
- NATRELLE Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S050
- Product code
- FWM
- Decision date
- 2022-12-29
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for modifications to Physician and Patient Labeling.
Current openFDA PMA Record#
- Device
- NATRELLE Saline-Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S050
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2022-12-29
- Decision code
- APPR
- Date received
- 2022-04-04
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to Physician and Patient Labeling.