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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 TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS181
Date Received08/18/1997
Decision Date11/26/1997
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 the acs tx2000vp(tm) coronary dilatation catheter with additional balloon sizes 2. 75, 3. 25, and 3. 75 x 15 mm and 20 mm.
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