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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 NamePALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameballoon stent
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS007
Date Received07/23/1997
Decision Date12/19/1997
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 the palmaz-schatz(tm) crown balloon expandable stent in diameters of 3. 0, 3. 5, and 4. 0 mm and lengths of 15, 22 and 30 mm. In addition approval for primary stenting of de novo lesions up to 25 mm in length and other modifications to the current label.
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