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 EXACT SPINE SEALANT SYSTEM |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P080013 |
Supplement Number | S013 |
Date Received | 04/18/2016 |
Decision Date | 07/15/2016 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to three of the polymer resins used to make the Biodome BIO-SET needless access system that is a component of the PEG (polyethylene glycol) vial. |
|
|