PMA P990075S015

Device: SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S015
Product code: FWM
Decision date: 2006-01-20
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: APPROVAL FOR AN OPTIONAL MANUFACTURING METHOD FOR THE ROUND SHELLS. MORE SPECIFICALLY, APPROVAL FOR A SPRAY-FORMING PROCESS FOR SHELLS USED FOR ROUND STYLES 1600, 2000, 2600, 3000, 1400 AND 2400.

Current openFDA PMA Record#

Device: SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S015
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2006-01-20
Decision code: APPR
Date received: 2004-08-24
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN OPTIONAL MANUFACTURING METHOD FOR THE ROUND SHELLS. MORE SPECIFICALLY, APPROVAL FOR A SPRAY-FORMING PROCESS FOR SHELLS USED FOR ROUND STYLES 1600, 2000, 2600, 3000, 1400 AND 2400.