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SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY

FDA premarket approval P990075/S004 · decided 2001-09-05

Approval details

PMA number
P990075
Supplement
S004
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY
Applicant
Mentor Worldwide, LLC
Date received
2001-07-10
Decision date
2001-09-05
Days to decision
57 days
Decision code
APPR
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
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.

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