PMA P030053S083

Device: MENTOR™ MemoryGel™ Enhance Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S083
Product code: FTR
Decision date: 2026-05-11
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: approval of the for revisions to the Statistical Analysis Plan (SAP) for the post-approval study (PAS) referenced above. The SAP revision has been submitted to comply with the conditions of approval outlined in our approval order for P030053/S069.

Current openFDA PMA Record#

Device: MENTOR™ MemoryGel™ Enhance Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S083
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2026-05-11
Decision code: APPR
Date received: 2025-08-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the for revisions to the Statistical Analysis Plan (SAP) for the post-approval study (PAS) referenced above. The SAP revision has been submitted to comply with the conditions of approval outlined in our approval order for P030053/S069.