PMA P120011S008
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S008
- Product code
- FWM
- Decision date
- 2016-11-07
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Change in the device sampling plan for endotoxin testing.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S008
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2016-11-07
- Decision code
- OK30
- Date received
- 2016-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the device sampling plan for endotoxin testing.