PMA P120011S001
- Device
- IDEAL IMPLANT SALINE FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S001
- Product code
- FWM
- Decision date
- 2015-08-27
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- AN INCREASE IN THE SCALE AND CAPACITY OF SHELL PRODUCTION EQUIPMENT, AND THE ELIMINATION FOR THE NEED OF THE CONTRACT MANUFACTURER TO DILUTE THE SILICONE DISPERSION MATERIAL.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT SALINE FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S001
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2015-08-27
- Decision code
- OK30
- Date received
- 2015-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN INCREASE IN THE SCALE AND CAPACITY OF SHELL PRODUCTION EQUIPMENT, AND THE ELIMINATION FOR THE NEED OF THE CONTRACT MANUFACTURER TO DILUTE THE SILICONE DISPERSION MATERIAL.