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 | S027 |
Date Received | 08/11/2023 |
Decision Date | 09/05/2023 |
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 Change in the test method for elemental impurity specifications of the sodium borate component to comply with USP <232> and USP <233>. |
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