|
Device | IDEAL IMPLANT Structured Breast Implant |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Bimini Health Tech 420 Stevens Ave. Suite 220 Solana Beach, CA 92075 |
PMA Number | P120011 |
Supplement Number | S012 |
Date Received | 06/11/2018 |
Decision Date | 08/06/2018 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an extension of the shelf life for the fill tube assembly (FTA) from 3 years to 5 years |