DuraSeal Exact Spine Sealant System 3mL & 5mL
FDA premarket approval P080013/S014 · decided 2018-01-24
Approval details
- PMA number
- P080013
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- DuraSeal Exact Spine Sealant System 3mL & 5mL
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2017-07-28
- Decision date
- 2018-01-24
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for labeling changes based on the Postmarket Approval Study results.
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