PMA P990075S009

Device: SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS.
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S009
Product code: FWM
Decision date: 2002-09-03
Classification: Prosthesis, Breast, Inflatable, Internal, Saline
Generic name: Prosthesis, breast, inflatable, internal, saline
Approval order statement: APPROVAL FOR REVISED LABELING THAT REFLECTS 5-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: S009
Product code: FWM
Generic name: Prosthesis, breast, inflatable, internal, saline
Decision date: 2002-09-03
Decision code: APPR
Date received: 2002-07-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISED LABELING THAT REFLECTS 5-YEAR POST-APPROVAL STUDY DATA.