| 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 MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY |
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| Generic Name | STENT, CORONARY |
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| Applicant | Cordis Corp.
14201 NW 60th Ave.
Miami Lakes, FL 33014 |
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| PMA Number | P900043 |
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| Supplement Number | S013 |
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| Date Received | 11/25/1998 |
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| Decision Date | 04/15/1999 |
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| Withdrawal Date | 09/02/2008 |
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| Product Code |
MAF |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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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