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 | CraniSeal Dural Sealant |
Generic Name | Sealant, dural |
Applicant | Pramand, LLC 201 Burlington Road, Suite 210 Bedford, MA 01730 |
PMA Number | P220014 |
Date Received | 09/02/2022 |
Decision Date | 07/06/2023 |
Product Code |
NQR |
Docket Number | 23M-3158 |
Notice Date | 07/28/2023 |
Advisory Committee |
Neurology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the CraniSeal Dural Sealant. The device is indicated for use in patients >= 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 |
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