DURASEAL (R) EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S012 · decided 2016-02-03
Approval details
- PMA number
- P080013
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- DURASEAL (R) EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2015-07-24
- Decision date
- 2016-02-03
- Days to decision
- 194 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
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