PMA P130014S004
- Device
- Adherus AutoSpray Dural Sealant
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S004
- Product code
- NQR
- Decision date
- 2017-06-02
- Classification
- Sealant, Dural
- Generic name
- Sealant, dural
- Approval order statement
- Addition of a secondary supplier for polyolefin elastomer spike caps.
Current openFDA PMA Record#
- Device
- Adherus AutoSpray Dural Sealant
- Applicant
- Stryker Leibinger GmbH & Co KG
- PMA number
- P130014
- Supplement
- S004
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2017-06-02
- Decision code
- OK30
- Date received
- 2017-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a secondary supplier for polyolefin elastomer spike caps.