PMA P030053S065

Device: MENTOR MemoryGel Breast Implants
Applicant: Mentor Corp.
Product code: FTR
Decision date: 2022-03-08
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval of the revised statistical analysis plan (SAP) for the post-approval study (PAS) referenced above. The SAP has been submitted to align with protocol changes approved in amendment 5 (P030053/S063 and P060028/S042).

Current openFDA PMA Record

Device: MENTOR MemoryGel Breast Implants
Applicant: Mentor Corp.
PMA number: P030053
Supplement: S065
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2022-03-08
Decision code: APPR
Date received: 2022-02-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised statistical analysis plan (SAP) for the post-approval study (PAS) referenced above. The SAP has been submitted to align with protocol changes approved in amendment 5 (P030053/S063 and P060028/S042).