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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
via crescentino, sn
saluggia, vc 13040
PMA NumberP900060
Supplement NumberS019
Date Received05/14/1999
Decision Date06/01/1999
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name CPHV(TM) OptiForm(TM) Valve and will be available in the following model numbers and sizes: Aortic Model F500 (sizes 19, 21, 23, 25, 27, 29, and 31 mm), and Mitral Model F700 (sizes 21, 23, 25, 27, 29, 31, and 33 mm). The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.