PMA P130014S014
- Device
- Adherus AutoSpray Dural Sealant, NUS-106
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S014
- Product code
- NQR
- Decision date
- 2022-02-14
- Generic name
- Sealant, dural
- Approval order statement
- Shift in the tolerance range for the Nozzle-Insert component of the Adherus AutoSpray Dural Sealant.
Current openFDA PMA Record#
- Device
- Adherus AutoSpray Dural Sealant, NUS-106
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S014
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2022-02-14
- Decision code
- OK30
- Date received
- 2022-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Shift in the tolerance range for the Nozzle-Insert component of the Adherus AutoSpray Dural Sealant.