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. |
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Device | PALMAZ-SCHATZ(R) MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY(TM) OVER THE WIRE DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P900043 |
Supplement Number | S023 |
Date Received | 02/04/2000 |
Decision Date | 05/24/2000 |
Withdrawal Date
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09/02/2008 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the labeling for the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent with Dynasty Over-the-Wire Delivery System to include 6-month data. |
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