| 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 | ADHERUS AUTOSPRAY DURAL SEALANT |
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| Generic Name | Sealant, dural |
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| Applicant | HYPERBRANCH MEDICAL TECHNOLOGY, INC.
800-12 Capitola Drive
Durham, NC 27713 |
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| PMA Number | P130014 |
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| Date Received | 05/14/2013 |
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| Decision Date | 03/30/2015 |
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| Product Code |
NQR |
| Docket Number | 15M-1065 |
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| Notice Date | 04/17/2015 |
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| Advisory Committee |
Neurology |
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| Clinical Trials | NCT01158378
|
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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 ADHERUS AUTOSPRAY DURAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE 13 YEARS OF AGE AND OLDER, AS AN ADJUNCT TO STANDARD METHODS OF DURAL REPAIR, SUCH AS WHEN USING SUTURES, TO PROVIDEWATERTIGHT CLOSURE DURING CRANIAL PROCEDURES. |
| 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: |
S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013
S014 S015 S016 S017 S018 S019 |
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