PMA P120011S004
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S004
- Product code
- FWM
- Decision date
- 2016-05-11
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Replacement of dry heat sterilization temperature sensors from pyrobuttons to thermocouples and added digital temperature chart printout, located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, California, 92780.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S004
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2016-05-11
- Decision code
- OK30
- Date received
- 2016-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of dry heat sterilization temperature sensors from pyrobuttons to thermocouples and added digital temperature chart printout, located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, California, 92780.