DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S003 · decided 2006-11-17
Approval details
- PMA number
- P040034
- Supplement
- S003
- 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
- 2006-05-24
- Decision date
- 2006-11-17
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE AT MILLSTONE MEDICAL OUTSOURCING, LLC, FALL RIVER, MASSACHUSETTS AND AN ADDITIONAL STERILIZATION SITE AT BEAMONE, LLC, LIMA, OHIO.
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