PMA P040034S035
- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S035
- Product code
- NQR
- Decision date
- 2022-10-07
- Generic name
- Sealant, dural
- Approval order statement
- Change in the raw material supplier of the laminated film component of the Tyvek Pouch used in packaging the DuraSeal products.
Current openFDA PMA Record#
- Device
- DuraSeal Dural Sealant System
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S035
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2022-10-07
- Decision code
- OK30
- Date received
- 2022-09-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the raw material supplier of the laminated film component of the Tyvek Pouch used in packaging the DuraSeal products.