PMA P080013S014
- Device
- DuraSeal Exact Spine Sealant System 3mL & 5mL
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S014
- Product code
- NQR
- Decision date
- 2018-01-24
- Classification
- Sealant, Dural
- Generic name
- Sealant, dural
- Approval order statement
- Approval for labeling changes based on the Postmarket Approval Study results.
Current openFDA PMA Record#
- Device
- DuraSeal Exact Spine Sealant System 3mL & 5mL
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P080013
- Supplement
- S014
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2018-01-24
- Decision code
- APPR
- Date received
- 2017-07-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes based on the Postmarket Approval Study results.