Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant |
Generic Name | Sealant, dural |
Applicant | HYPERBRANCH MEDICAL TECHNOLOGY, INC. 800-12 Capitola Drive Durham, NC 27713 |
PMA Number | P130014 |
Supplement Number | S018 |
Date Received | 08/11/2023 |
Decision Date | 08/25/2023 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacement of the server system and related equipment which processes raw data from analytical instrumentation. |
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