PMA P040034S025
- Device
- DURASEAL DURAL SEALANT SYSTEM
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S025
- Product code
- NQR
- Decision date
- 2016-07-15
- Classification
- Sealant, Dural
- Generic name
- Sealant, dural
- Approval order statement
- Approval for changes to three of the polymer resins used to make the Biodome BIO-SET needless access system that is a component of the PEG (polyethylene glycol) vial.
Current openFDA PMA Record#
- Device
- DURASEAL DURAL SEALANT SYSTEM
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P040034
- Supplement
- S025
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2016-07-15
- Decision code
- APPR
- Date received
- 2016-04-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to three of the polymer resins used to make the Biodome BIO-SET needless access system that is a component of the PEG (polyethylene glycol) vial.