| 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 | TELESCOPE PTCA BALLOON CATHETER |
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| Classification Name | catheters, transluminal coronary angioplasty, percutaneous |
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| Generic Name | ptca catheter |
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| Regulation Number | 870.5100 |
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| Applicant | C.R. BARD, INC. |
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| PMA Number | P790017 |
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| Supplement Number | S064 |
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| Date Received | 01/20/1998 |
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| Decision Date | 02/12/1998 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | real-time process |
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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
Approval to sell the usci(r) telescope(tm) balloon dilatation catheter with hydro/pel(r) coating to cordis corp. For distribution. |
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