DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S008 · decided 2014-02-06
Approval details
- PMA number
- P080013
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-03-25
- Decision date
- 2014-02-06
- Days to decision
- 318 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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