DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S009 · decided 2013-11-15
Approval details
- PMA number
- P080013
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-06-04
- Decision date
- 2013-11-15
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR A CHANGE TO THE LAYERING OF KITS IN THE CASE BOX USED FOR STERILIZATION.
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