DuraSeal TM Dural Sealant System
FDA premarket approval P040034/S026 · decided 2017-08-17
Approval details
- PMA number
- P040034
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DuraSeal TM Dural Sealant System
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2017-07-21
- Decision date
- 2017-08-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Change in manufacturing site of one of the suppliers.
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