PMA P120011S002

Device: IDEAL IMPLANT SALINE FILLED BREAST IMPLANT
Applicant: Bimini Health Tech
PMA number: P120011
Supplement: S002
Product code: FWM
Decision date: 2016-04-25
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: Approval for a change to the currently approved brand name of IDEAL IMPLANT® Saline-filled Breast Implant to IDEAL IMPLANT® Structured Breast Implant.

Current openFDA PMA Record#

Device: IDEAL IMPLANT SALINE FILLED BREAST IMPLANT
Applicant: Bimini Health Tech
PMA number: P120011
Supplement: S002
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2016-04-25
Decision code: APPR
Date received: 2015-11-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change to the currently approved brand name of IDEAL IMPLANT® Saline-filled Breast Implant to IDEAL IMPLANT® Structured Breast Implant.