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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 NameCATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter with ultrasound
Regulation Number870.5100
ApplicantENDOSONICS CORP.
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: manufacturing
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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