PMA P120011S013
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S013
- Product code
- FWM
- Decision date
- 2018-08-22
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Replace the current 100% shell inspection for thickness with a zero acceptance number (c=0, AQL=1.0%) shell sampling plan for thickness at the Vesta Intermediate Funding Inc located at 9900 S 57th Street, Franklin, Wisconsin.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S013
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2018-08-22
- Decision code
- OK30
- Date received
- 2018-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the current 100% shell inspection for thickness with a zero acceptance number (c=0, AQL=1.0%) shell sampling plan for thickness at the Vesta Intermediate Funding Inc located at 9900 S 57th Street, Franklin, Wisconsin.