PMA P120011S027
- Device
- Ideal Implant Structured Breast implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S027
- Product code
- FWM
- Decision date
- 2023-11-18
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Transferring of certain QC tests to the manufacturing site.
Current openFDA PMA Record#
- Device
- Ideal Implant Structured Breast implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S027
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2023-11-18
- Decision code
- OK30
- Date received
- 2023-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transferring of certain QC tests to the manufacturing site.