|
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 | S020 |
Date Received | 06/23/2020 |
Decision Date | 07/22/2020 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes to add additional information on potential risks and adverse events identified in the Summary of Safety and Effectiveness Data for the DuraSeal Exact Spine Sealant System. |