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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 NameTHOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilation catheters
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Supplement NumberS066
Date Received12/11/1996
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
Approval Order Statement 
Approval for thor(tm) ptca dilatation catheters with 10 mm and 40 mm long balloons.
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