PMA P080013S011

Device: DURASEAL EXACT SPINE SEALANT
Applicant: Integra LifeSciences Corporation
PMA number: P080013
Supplement: S011
Product code: NQR
Decision date: 2015-05-11
Classification: Sealant, Dural
Generic name: Sealant, dural
Approval order 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 POTENTIALLY HAVE BEEN SEEN OUTSIDE OF THE STUDY WINDOW THUS MAINTAINING CONTROL OVER FOLLOW-UP COMPLIANCE.

Current openFDA PMA Record#

Device: DURASEAL EXACT SPINE SEALANT
Applicant: Integra LifeSciences Corporation
PMA number: P080013
Supplement: S011
Product code: NQR
Generic name: Sealant, dural
Decision date: 2015-05-11
Decision code: APPR
Date received: 2015-02-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol - OSB
Approval order 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 POTENTIALLY HAVE BEEN SEEN OUTSIDE OF THE STUDY WINDOW THUS MAINTAINING CONTROL OVER FOLLOW-UP COMPLIANCE.