DuraSeal Exact Spine Sealant System
FDA premarket approval P080013/S020 · decided 2020-07-22
Approval details
- PMA number
- P080013
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DuraSeal Exact Spine Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2020-06-23
- Decision date
- 2020-07-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Approval for labeling changes to add additional information on potential risks and adverse events identified in the Summary of Safety and Effectiveness Data for the DuraSeal Exact Spine Sealant System.
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