PMA P130014S012

Device
Adherus AutoSpray ET Dural Sealant
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S012
Product code
NQR
Decision date
2021-09-15
Generic name
Sealant, dural
Approval order statement
Alternate supplier to supply ET parts for the delivery system of Adherus AutoSpray ET Dural Sealant.

Current openFDA PMA Record#

Device
Adherus AutoSpray ET Dural Sealant
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S012
Product code
NQR
Generic name
Sealant, dural
Decision date
2021-09-15
Decision code
OK30
Date received
2021-08-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier to supply ET parts for the delivery system of Adherus AutoSpray ET Dural Sealant.