| 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 | INSTAT COLLAGEN ABSORBABLE HEMOSTAT |
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| Classification Name | agent, absorbable hemostatic, collagen based |
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| Generic Name | absorbable hemostatic agents, collagen based |
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| Regulation Number | 878.4490 |
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| Applicant | ETHICON, INC. |
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| PMA Number | P830079 |
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| Supplement Number | S012 |
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| Date Received | 08/28/1998 |
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| Decision Date | 05/05/1999 |
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| Product Code | |
| Advisory Committee |
General & Plastic Surgery |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | location change: manufacturer |
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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 additional location for final product release located at ethicon, inc. , u. S. Route 22, somerville, nj 08876 and duplication of final packaging process at ethicon, inc. , road 183 km 8. 3, industrial area hato, san lorenzo, puerto rico 00754. |
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