DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S003 · decided 2011-02-18
Approval details
- PMA number
- P080013
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2010-01-20
- Decision date
- 2011-02-18
- Days to decision
- 394 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE REPLACEMENT OF THE CURRENT DURASEAL SPINE SEALANT POLYETHYLENE GLYCOL (PEG) FORMULATION WITH A LOWER MOLECULAR WEIGHT FORMULATION.
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