PMA P120011S003

Device: IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
Applicant: Bimini Health Tech
PMA number: P120011
Supplement: S003
Product code: FWM
Decision date: 2016-11-17
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted

Current openFDA PMA Record#

Device: IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
Applicant: Bimini Health Tech
PMA number: P120011
Supplement: S003
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2016-11-17
Decision code: APPR
Date received: 2016-03-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted