PMA P120011S005
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S005
- Product code
- FWM
- Decision date
- 2016-05-13
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Manufacturing sequence change: baffle shell slitting process was moved to follow the 2-inch hole die-cutting step, instead of preceding it. The facility is located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, CA 92780.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S005
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2016-05-13
- Decision code
- OK30
- Date received
- 2016-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing sequence change: baffle shell slitting process was moved to follow the 2-inch hole die-cutting step, instead of preceding it. The facility is located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, CA 92780.