PMA P120011S007
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S007
- Product code
- FWM
- Decision date
- 2016-10-20
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i.e., packaged and sterilized) implants during commercial production start-up, will be discontinued. However, valve competence testing on valves in finished implants will continue to meet the requirements of the AQL sampling specified in Ideal Implant’s Finished Product Specification FP 001.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S007
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2016-10-20
- Decision code
- OK30
- Date received
- 2016-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i.e., packaged and sterilized) implants during commercial production start-up, will be discontinued. However, valve competence testing on valves in finished implants will continue to meet the requirements of the AQL sampling specified in Ideal Implant’s Finished Product Specification FP 001.