PMA P120011S023
- Device
- IDEAL IMPLANT® Structured Breast Implant
- Applicant
- Bimini Health Tech
- Product code
- FWM
- Decision date
- 2023-02-01
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for a new manufacturing site at Bentec Medical OpCo, LLC, 1380 E Beamer St. Woodland CA 95776.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT® Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S023
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2023-02-01
- Decision code
- APPR
- Date received
- 2021-08-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new manufacturing site at Bentec Medical OpCo, LLC, 1380 E Beamer St. Woodland CA 95776.