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. |
|
Device | DuraSeal Dural Sealant System |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P040034 |
Supplement Number | S029 |
Date Received | 06/11/2019 |
Decision Date | 07/11/2019 |
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 Use of an additional freezer for the production of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System. |
|
|