PMA P040034S026
- Device
- DuraSeal TM Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S026
- Product code
- NQR
- Decision date
- 2017-08-17
- Classification
- Sealant, Dural
- Generic name
- Sealant, dural
- Approval order statement
- Change in manufacturing site of one of the suppliers.
Current openFDA PMA Record#
- Device
- DuraSeal TM Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S026
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2017-08-17
- Decision code
- OK30
- Date received
- 2017-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in manufacturing site of one of the suppliers.