| 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 | CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER |
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| Classification Name | catheters, transluminal coronary angioplasty, percutaneous |
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| Generic Name | ptca catheter with ultrasound |
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| Regulation Number | 870.5100 |
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| Applicant | ENDOSONICS CORP. |
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| PMA Number | P910031 |
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| Supplement Number | S007 |
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| Date Received | 01/26/1996 |
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| Decision Date | 05/30/1996 |
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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 | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for: 1)an additional manufacturing site (13900 alton parkway, suite 122, irvine, ca, 92718); 2) an alternate sterilization site (griffith micro science, 4900 gifford ave. , los angeles, ca, 90058); and 3) an increase in the shelf life from one to two years. |
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