PMA P990075S014

Device: SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S014
Product code: FWM
Decision date: 2004-01-16
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: APPROVAL FOR REVISED LABELING THAT REFLECTS 7-YEAR POST-APPROVAL STUDY DATA.

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: S014
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2004-01-16
Decision code: APPR
Date received: 2003-11-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISED LABELING THAT REFLECTS 7-YEAR POST-APPROVAL STUDY DATA.