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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.
 
DeviceCATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
ABBOTT VASCULAR DEVICES
400 saginaw dr.
redwood city, CA 94063
PMA NumberP910031
Supplement NumberS007
Date Received01/26/1996
Decision Date05/30/1996
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: 1)an additional manufacturing site (13900 alton parkway, suite 122, irvine, ca, 92718); 2) an alternate sterilization site (griffith micro science, 4900 gifford ave. , los angeles, ca, 90058); and 3) an increase in the shelf life from one to two years.
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