PMA P120011S012
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S012
- Product code
- FWM
- Decision date
- 2018-08-06
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for an extension of the shelf life for the fill tube assembly (FTA) from 3 years to 5 years
Current openFDA PMA Record#
- Device
- IDEAL IMPLANT Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S012
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2018-08-06
- Decision code
- APPR
- Date received
- 2018-06-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an extension of the shelf life for the fill tube assembly (FTA) from 3 years to 5 years