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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 NameGUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantCARDIOVASCULAR DYNAMICS, INC.
PMA NumberP910031
Supplement NumberS017
Date Received10/14/1997
Decision Date11/10/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the trade name from the lynx(tm) to the guardian(tm) coronary balloon dilatation ptca catheter.
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