PMA P080013S026
- Device
- DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL)
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S026
- Product code
- NQR
- Decision date
- 2023-05-24
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- Changing the quantification test method for determining elemental impurities present in one of the raw materials.
Current openFDA PMA Record#
- Device
- DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL)
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S026
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2023-05-24
- Decision code
- OK30
- Date received
- 2023-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changing the quantification test method for determining elemental impurities present in one of the raw materials.