PMA P120011S018
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S018
- Product code
- FWM
- Decision date
- 2020-04-03
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Add 100% visual inspection and manual flash removal from the valve seat after cryogenic deflashing.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S018
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2020-04-03
- Decision code
- OK30
- Date received
- 2020-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add 100% visual inspection and manual flash removal from the valve seat after cryogenic deflashing.