| 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. |
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| Trade Name | PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM |
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| Classification Name | stent, coronary |
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| Generic Name | balloon stent |
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| Applicant | CORDIS CORP. |
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| PMA Number | P900043 |
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| Supplement Number | S010 |
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| Date Received | 05/12/1998 |
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| Decision Date | 08/20/1998 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a decrease in the distal balloon leg length of the powergrip(tm) delivery catheter from 3 mm to 1 mm. |
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