PMA P030053S076

Device: MemoryGel Enhance Silicone Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S076
Product code: FTR
Decision date: 2025-01-17
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P030053/S069.

Current openFDA PMA Record#

Device: MemoryGel Enhance Silicone Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S076
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2025-01-17
Decision code: APPR
Date received: 2024-12-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P030053/S069.