PMA P990075S062

Device: MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S062
Product code: FWM
Decision date: 2025-05-21
Classification: General, Plastic Surgery
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: for implementation of new mold release spray to be used on the rubber processing mill for silicone elastomers used in the manufacturing of MemoryGel™ (P030053), MemoryShape™ (P060028) and Saline-Filled/SPECTRUM™ Breast Implants.

Current openFDA PMA Record#

Device: MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S062
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2025-05-21
Decision code: OK30
Date received: 2025-04-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for implementation of new mold release spray to be used on the rubber processing mill for silicone elastomers used in the manufacturing of MemoryGel™ (P030053), MemoryShape™ (P060028) and Saline-Filled/SPECTRUM™ Breast Implants.