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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namestent, coronary
Generic Namestent, coronary
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
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/material
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.