PMA P080013S017
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S017
- Product code
- NQR
- Decision date
- 2019-07-11
- Classification
- Sealant, Dural
- Generic name
- Sealant, dural
- Approval order statement
- Use of an additional freezer for the production of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System.
Current openFDA PMA Record#
- Device
- DuraSeal Exact Spine Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S017
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2019-07-11
- Decision code
- OK30
- Date received
- 2019-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an additional freezer for the production of the DuraSeal Dural Sealant System and DuraSeal Exact Spine Sealant System.