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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilation catheters
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Supplement NumberS065
Date Received11/29/1996
Decision Date04/30/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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