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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.
 
DeviceACS RX ROCKET CORONARY DILATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS188
Date Received04/16/1998
Decision Date06/29/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of two quality control tests to the manufacturing process of the acs rx rocket(tm) coronary dilatation catheter.
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