PMA P120011S025
- Device
- Puregraft Serene Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S025
- Product code
- FWM
- Decision date
- 2024-08-16
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for updated Instructions for Use and Patient Information Booklet
Current openFDA PMA Record#
- Device
- Puregraft Serene Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S025
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2024-08-16
- Decision code
- APPR
- Date received
- 2023-02-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated Instructions for Use and Patient Information Booklet