PMA P220014S013

Device: CraniSeal™ Dural Sealant
Applicant: Pramand, LLC
PMA number: P220014
Supplement: S013
Product code: NQR
Decision date: 2026-10-01
Classification: Neurology
Generic name: Sealant, dural
Approval order statement: Approval of the revised protocol for the CraniSeal Registry New Enrollment Post-Approval Study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220014.

Current openFDA PMA Record#

Device: CraniSeal™ Dural Sealant
Applicant: Pramand, LLC
PMA number: P220014
Supplement: S013
Product code: NQR
Generic name: Sealant, dural
Decision date: 2026-10-01
Decision code: APPR
Date received: 2026-09-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the CraniSeal Registry New Enrollment Post-Approval Study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220014.