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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 NameACS RX ESPRIT CORONARY DILATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS190
Date Received05/21/1998
Decision Date07/30/1998
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 for additional balloon sizes for the acs avenger(tm) coronary dilatation catheter (quarter sizes within the range of 2. 25-3. 75 mm for the currently marketed 15mm and 20mm balloon lengths and half sizes in the rang eof 2. 5-4. 0mm for a 25mm balloon length.
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