DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S007 · decided 2006-11-02
Approval details
- PMA number
- P040034
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2006-08-24
- Decision date
- 2006-11-02
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR USE OF DATA COLLECTED AT ELEVATED TEMPERATURES (I.E., ACCELERATED AGING DATA) TO DETERMINE FUTURE SHELF LIFE CLAIMS FOR THE DEVICE, APPLYING A CORRELATION FACTOR OF Q10=3. THE USE OF THE CORRELATION FACTOR WITH TEST DATA OBTAINED AT 35 DEGREES C COLLECTED OUT TO 26 WEEKS ACCURATELY PREDICTS PRODUCT EXPIRATION DATING TO 18 MONTHS, REAL-TIME.
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