DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S004 · decided 2011-09-29
Approval details
- PMA number
- P080013
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2011-03-02
- Decision date
- 2011-09-29
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COVIDIEN, LP IN NORTH HAVEN, CONNECTICUT.
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