PMA P120011S024
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S024
- Product code
- FWM
- Decision date
- 2022-01-26
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Trelleborg Sealing Solutions US, Inc. to resume fabrication of silicone shells using new DipTech automated equipment.
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S024
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2022-01-26
- Decision code
- OK30
- Date received
- 2021-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Trelleborg Sealing Solutions US, Inc. to resume fabrication of silicone shells using new DipTech automated equipment.