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 | Rocket KCH Fetal Bladder Drain |
Classification Name | stent, bladder, fetal |
Generic Name | stent, bladder, fetal |
Applicant |
ROCKET MEDICAL PLC |
1151 hope st. |
stamford, CT 06907 |
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HDE Number | H970001 |
Supplement Number | S002 |
Date Received | 09/19/2019 |
Decision Date | 10/16/2019 |
Product Code | |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the professional instructions for use to include an additional warning statement regarding off-label use and revisions to the directions for use including an expanded caution statement to address complaints related to device kinking. |
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