ADHERUS AUTOSPRAY DURAL SEALANT
FDA premarket approval P130014 · decided 2015-03-30
Approval details
- PMA number
- P130014
- Trade name
- ADHERUS AUTOSPRAY DURAL SEALANT
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2013-05-14
- Decision date
- 2015-03-30
- Days to decision
- 685 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- APPROVAL FOR THE ADHERUS AUTOSPRAY DURAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE 13 YEARS OF AGE AND OLDER, AS AN ADJUNCT TO STANDARD METHODS OF DURAL REPAIR, SUCH AS WHEN USING SUTURES, TO PROVIDEWATERTIGHT CLOSURE DURING CRANIAL PROCEDURES.
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