PMA P080013S027
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S027
- Product code
- NQR
- Decision date
- 2023-09-05
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Change in the test method for elemental impurity specifications of the sodium borate component to comply with USP <232> and USP <233>.
Current openFDA PMA Record#
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S027
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2023-09-05
- Decision code
- OK30
- Date received
- 2023-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the test method for elemental impurity specifications of the sodium borate component to comply with USP and USP .