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SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS

FDA premarket approval P990075/S015 · decided 2006-01-20

Approval details

PMA number
P990075
Supplement
S015
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Generic name
Prosthesis, breast, inflatable, internal, saline
Applicant
Mentor Worldwide, LLC
Date received
2004-08-24
Decision date
2006-01-20
Days to decision
514 days
Decision code
APPR
Product code
FWM
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
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.

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