Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | DURASEAL DURAL SEALANT SYSTEM |
Generic Name | Sealant, dural |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P040034 |
Supplement Number | S007 |
Date Received | 08/24/2006 |
Decision Date | 11/02/2006 |
Product Code |
NQR |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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