Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | IDEAL IMPLANT SALINE-FILLED 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 | S004 |
Date Received | 04/15/2016 |
Decision Date | 05/11/2016 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacement of dry heat sterilization temperature sensors from pyrobuttons to thermocouples and added digital temperature chart printout, located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, California, 92780. |
|
|