PMA P120011S011
- Device
- Ideal Implant Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S011
- Product code
- FWM
- Decision date
- 2018-06-28
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Change to the bubble specification for the inner and outer shell to increase the allowable number of microscopic bubbles less than or equal to 0.020 inches in size from 5 bubbles to 10 bubbles.
Current openFDA PMA Record#
- Device
- Ideal Implant Structured Breast Implant
- Applicant
- Bimini Health Tech
- PMA number
- P120011
- Supplement
- S011
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2018-06-28
- Decision code
- OK30
- Date received
- 2018-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the bubble specification for the inner and outer shell to increase the allowable number of microscopic bubbles less than or equal to 0.020 inches in size from 5 bubbles to 10 bubbles.