PMA P060028S058

Device: MENTOR™ MemoryShape™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S058
Product code: FTR
Decision date: 2026-07-21
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: For introduction of an Overall Compliance Rate in addition to the existing FDA-defined target rate and Introduction of a Call Center to assist patient troubleshooting concerns

Current openFDA PMA Record#

Device: MENTOR™ MemoryShape™ Breast Implants
Applicant: Mentor Worldwide, LLC
PMA number: P060028
Supplement: S058
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2026-07-21
Decision code: APPR
Date received: 2025-10-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: For introduction of an Overall Compliance Rate in addition to the existing FDA-defined target rate and Introduction of a Call Center to assist patient troubleshooting concerns