DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S011 · decided 2009-10-23
Approval details
- PMA number
- P040034
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2009-06-23
- Decision date
- 2009-10-23
- Days to decision
- 122 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, NORTH HAVEN, CONNECTICUT.
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