| 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 | ACS RX ESPRIT CORONARY DILATION CATHETER |
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| Classification Name | catheters, transluminal coronary angioplasty, percutaneous |
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| Generic Name | coronary dilatation catheter |
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| Regulation Number | 870.5100 |
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| Applicant | GUIDANT CORP. |
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| PMA Number | P810046 |
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| Supplement Number | S189 |
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| Date Received | 04/30/1998 |
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| Decision Date | 06/27/1998 |
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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 | location change: sterilizer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for an alternate e-beam sterilization facility located at titan scan systems, 9020 activity rd. , suite d, san diego, ca 92126. |
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