PMA P130014S010

Device
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S010
Product code
NQR
Decision date
2021-03-05
Generic name
Sealant, dural
Approval order statement
Replacement of four ovens for drying glassware.

Current openFDA PMA Record#

Device
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S010
Product code
NQR
Generic name
Sealant, dural
Decision date
2021-03-05
Decision code
OK30
Date received
2021-02-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of four ovens for drying glassware.