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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 NumberS182
Date Received11/24/1997
Decision Date01/27/1998
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an e-beam sterilization process validation protocol and a manufacturing site located at guidant corporation, advanced cardiovascular systems, 26531 ynez rd. , temecula, ca 92591-4628.
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