DURASEAL EXACT SPINE SEALANT
FDA premarket approval P080013/S011 · decided 2015-05-11
Approval details
- PMA number
- P080013
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- DURASEAL EXACT SPINE SEALANT
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2015-02-02
- Decision date
- 2015-05-11
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:1) CHANGE THE DEFINITION OF THE MINIMUM NECESSARY FOLLOW-UP FROM 60 TO 45 DAYS FOR THE RETROSPECTIVE CONTROL SUBJECTS ONLY; AND 2) ALLOW ANY NEW STUDY SITES THAT DO NOT HAVE 90 DAY STANDARD OF CARE VISITS TO ENROLL PROSPECTIVE SUBJECTS ONLY (DURASEAL AND/OR CONTROL). THIS WOULD ALLOW NEW SITES TO CONTRIBUTE SUBJECTS PROSPECTIVELY INSIDE THE STUDY WINDOW (60 TO 120 DAYS), BUT EXCLUDE RETROSPECTIVE SUBJECTS THAT WOULD POTE
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