Adherus Autospray Dural Sealant

FDA premarket approval P130014 · Sealant, dural

PMA numberP130014

Approval

Applicant
Stryker Leibinger GmbH & Co KG
Received
May 14, 2013
Decision date
March 30, 2015 (APPR)
Supplements
20, latest July 15, 2026
Product code
NQR – Sealant, Dural

Official FDA PMA record

Approval order 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.