PMA P990074S045
- Device
- Natrelle Saline Filled Breast Implants
- Applicant
- Allergan
- Product code
- FWM
- Decision date
- 2021-10-27
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
Current openFDA PMA Record#
- Device
- Natrelle Saline Filled Breast Implants
- Applicant
- Allergan
- PMA number
- P990074
- Supplement
- S045
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2021-10-27
- Decision code
- APPR
- Date received
- 2021-03-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.