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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 NameGIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantCOOK, INC.
PMA NumberP910030
Supplement NumberS005
Date Received11/26/1996
Decision Date05/12/1997
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified version of the original gianturco-roubin coronary flex stent(tm). The device, as modified, will be marketed under the trade name gr ii(tm) coronary stent and is indicated for treatment of acute or threatened closure in patients with failed interventional therapy in vessels with reference diameters in the range of 2. 1 mm to 4. 0 mm.
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