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 | DuraSeal Exact Spine Sealant System 3mL & 5mL |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P080013 |
Supplement Number | S014 |
Date Received | 07/28/2017 |
Decision Date | 01/24/2018 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes based on the Postmarket Approval Study results. |
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