PMA P120011S006
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S006
- Product code
- FWM
- Decision date
- 2017-06-27
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for updated patient and physician labeling that includes 5 year follow-up clinical data
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S006
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2017-06-27
- Decision code
- APPR
- Date received
- 2016-07-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated patient and physician labeling that includes 5 year follow-up clinical data