PMA P120011S021
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S021
- Product code
- FWM
- Decision date
- 2021-06-29
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for a change to the product release testing method for the posterior valve-patch joint.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S021
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2021-06-29
- Decision code
- APPR
- Date received
- 2020-11-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the product release testing method for the posterior valve-patch joint.