PMA P130014S002

Device
ADHERUS AUTOSPRAY DURAL SEALANT
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S002
Product code
NQR
Decision date
2016-08-02
Classification
Sealant, Dural
Generic name
Sealant, dural
Approval order statement
Approval for changes in a nozzle design and packaging of the Adherus Autospray ET (Extended Tip) Dural Sealant.

Current openFDA PMA Record#

Device
ADHERUS AUTOSPRAY DURAL SEALANT
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S002
Product code
NQR
Generic name
Sealant, dural
Decision date
2016-08-02
Decision code
APPR
Date received
2016-02-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes in a nozzle design and packaging of the Adherus Autospray ET (Extended Tip) Dural Sealant.