PMA P120011S026
- Device
- Puregraft Serene Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S026
- Product code
- FWM
- Decision date
- 2024-03-15
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for changing the name from IDEAL IMPLANT® Structured Breast Implant to Puregraft Serene Breast Implant.
Current openFDA PMA Record#
- Device
- Puregraft Serene Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S026
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2024-03-15
- Decision code
- APPR
- Date received
- 2023-10-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changing the name from IDEAL IMPLANT® Structured Breast Implant to Puregraft Serene Breast Implant.