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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 MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY
Classification Namestent, coronary
Generic Nameballoon stent
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS013
Date Received11/25/1998
Decision Date04/15/1999
Product Code
MAF[ Registered Establishments with MAF ]
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 palmaz-schatz(tm) minicrown balloon expandable stent with dynasty(tm) over the wire delivery system (11 mm and 15 mm stent lengths with 2. 25, 2. 50, 2. 75, 3. 00, and 3. 25 mm balloon diameters). The device is indicated for improving coronary luminal diameter in the following: treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions (< 25mm) with a reference vessel diameters in the range of 2. 25 to 3. 25mm. Long term outcome (beyond 1 month) for this permanent implant is unknown at present.
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