| 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 | SCHNEIDER CHUBBY(TM) PTCA CATHETERS |
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| Classification Name | catheters, transluminal coronary angioplasty, percutaneous |
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| Generic Name | catheter |
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| Regulation Number | 870.5100 |
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| Applicant | SCHNEIDER INTL., LTD. |
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| PMA Number | P880027 |
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| Supplement Number | S042 |
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| Date Received | 11/06/1996 |
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| Decision Date | 02/04/1997 |
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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 - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Additional balloon sizes of 4. 5 and 5. 0 mm in the chubby ptca catheter line. |
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