PMA P030053S012

Device: MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S012
Product code: FTR
Decision date: 2013-04-05
Classification: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: APPROVAL FOR THE 6-YEAR UPDATE PATIENT AND PHYSICIAN LABELING FOR THE MEMORYGEL¿ SILICONE GEL-FILLED BREAST IMPLANT.

Current openFDA PMA Record#

Device: MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S012
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2013-04-05
Decision code: APPR
Date received: 2011-02-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE 6-YEAR UPDATE PATIENT AND PHYSICIAN LABELING FOR THE MEMORYGEL¿ SILICONE GEL-FILLED BREAST IMPLANT.