| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH |
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| Generic Name | Device, hemostasis, vascular |
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| Applicant | MORRIS INNOVATIVE RESEARCH INC
907 W.SECOND ST
BLOOMINGTON, IN 47403 |
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| PMA Number | P050043 |
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| Date Received | 11/23/2005 |
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| Decision Date | 08/20/2007 |
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| Product Code |
MGB |
| Docket Number | 07M-0344 |
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| Notice Date | 09/18/2007 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5, 6, AND 8 FRENCH. THE DEVICE IS INDICATED AS FOLLOWS: THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE IS INTENDED FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, OR 8 FRENCH PROCEDURAL SHEATHS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S004 S005 S002 S006 S001 S008 |
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