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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 NameJOMED JOCATH GLADIATOR PTCA CATHETER (OTW)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary, angioplasty, percutaneous & operative
Regulation Number870.5100
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP910031
Supplement NumberS021
Date Received12/06/2001
Decision Date08/01/2003
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the jomed jocath gladiator ptca catheter (otw). The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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