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 |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P080013 |
Supplement Number | S015 |
Date Received | 11/30/2017 |
Decision Date | 03/21/2018 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for manufacturing sites located at Avail/Med S.A. De C.V., C.Industrial Lt.001 Mz 105, No. 206905 Int.a.Col. Cd. Industrial, Tijuana, Baja California, Mexico 22444 for manufacture of the DuraSeal® Dural Sealant System and DuraSeal® Exact Spine Sealant System, and Synergy Health AST, LLC, 9020 Activity Road, Suite D, San Diego, California for sterilization of the devices. |
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