|
Device | DURASEAL DURAL SEALANT SYSTEM |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P040034 |
Supplement Number | S021 |
Date Received | 06/04/2013 |
Decision Date | 11/15/2013 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE LAYERING OF KITS IN THE CASE BOX USED FOR STERILIZATION. |