PMA P120011S020
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S020
- Product code
- FWM
- Decision date
- 2020-07-31
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- a change in manufacturing process at their approved TSS site
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S020
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2020-07-31
- Decision code
- OK30
- Date received
- 2020-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in manufacturing process at their approved TSS site