PMA P990075S004

Device: SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S004
Decision date: 2001-09-05
Approval order statement: APPROVAL FOR 1) AN INCREASE IN THE THICKNESS OF THE SHELL RADIUS/BASE FOR STYLE 5000PT AND 2) A DECREASE IN THICKNESS OF THE TEXTURED LAYER FROM 0.02" TO 0.01" FOR STYLES 5000, 5000PT, 6000 AND 6000PT. THE SECOND CHANGE EFFECTIVELY WITHDRAWS THE APPROVED CHANGE IN SUPPLEMENT 2.

Current openFDA PMA Record#

Device: SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY
Applicant: Mentor Worldwide, LLC
PMA number: P990075
Supplement: S004
Decision date: 2001-09-05
Decision code: APPR
Date received: 2001-07-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) AN INCREASE IN THE THICKNESS OF THE SHELL RADIUS/BASE FOR STYLE 5000PT AND 2) A DECREASE IN THICKNESS OF THE TEXTURED LAYER FROM 0.02" TO 0.01" FOR STYLES 5000, 5000PT, 6000 AND 6000PT. THE SECOND CHANGE EFFECTIVELY WITHDRAWS THE APPROVED CHANGE IN SUPPLEMENT 2.