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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 NameCHUBBY(TM) PTCA CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantSCHNEIDER INTL., LTD.
PMA NumberP880027
Supplement NumberS040
Date Received03/25/1996
Decision Date09/04/1996
Product Code
LOX
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the chubby sliding rail percutaneous transluminal coronary angioplasty (ptca) catheter.
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