PMA P130014S007

Device
Adherus AutoSpray ET Dural Sealant
Applicant
Stryker Leibinger GmbH & Co KG
PMA number
P130014
Supplement
S007
Product code
NQR
Decision date
2020-07-10
Generic name
Sealant, dural
Approval order statement
Approval for alternate transport packaging to allow the single unit sale of the 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
S007
Product code
NQR
Generic name
Sealant, dural
Decision date
2020-07-10
Decision code
APPR
Date received
2020-04-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for alternate transport packaging to allow the single unit sale of the Adherus AutoSpray ET Dural Sealant.