Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | HARRISON FETAL BLADDER STENT SET |
Classification Name | stent, bladder, fetal |
Generic Name | stent, bladder, fetal |
Applicant |
Cook Incorporated |
750 daniels way |
p.o. box 489 |
bloomington, IN 47402 |
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HDE Number | H960001 |
Supplement Number | S001 |
Date Received | 04/01/2008 |
Decision Date | 05/07/2008 |
Product Code | |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification in the sterilization procedure. |
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