PMA P990075S013

Device: MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S013
Product code: FWM
Decision date: 2003-08-14
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: CHANGE IN THE QUALITY CONTROL TEST SPECIFICATION TO REPLACE THE TENSILE STRENGTH SPECIFICATION WITH A BREAK FORCE SPECIFICATION FOR THE SILICONE ELASTOMER FILL TUBE COMPONENT OF THE MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES.

Current openFDA PMA Record#

Device: MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S013
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2003-08-14
Decision code: OK30
Date received: 2003-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE QUALITY CONTROL TEST SPECIFICATION TO REPLACE THE TENSILE STRENGTH SPECIFICATION WITH A BREAK FORCE SPECIFICATION FOR THE SILICONE ELASTOMER FILL TUBE COMPONENT OF THE MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES.