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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 STREAK & ACS FLOW TRACK 40
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 NumberS162
Date Received04/16/1996
Decision Date11/05/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of new product names to allow concurrent distributio by a second company. The devices, as modified, will be marketed under the trade names acs rx gazelle coronary dilatation catheter and acs rx flexflo coronary dilatation catheter.
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