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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 NameTELESCOPE PTCA BALLOON CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantC.R. BARD, INC.
PMA NumberP790017
Supplement NumberS064
Date Received01/20/1998
Decision Date02/12/1998
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 to sell the usci(r) telescope(tm) balloon dilatation catheter with hydro/pel(r) coating to cordis corp. For distribution.
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