PMA P220014S003

Device: CraniSeal Dural Sealant
Applicant: Pramand, LLC
PMA number: P220014
Supplement: S003
Product code: NQR
Decision date: 2025-02-28
Classification: Neurology
Generic name: Sealant, dural
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order dated July 6, 2023, for P220014

Current openFDA PMA Record#

Device: CraniSeal Dural Sealant
Applicant: Pramand, LLC
PMA number: P220014
Supplement: S003
Product code: NQR
Generic name: Sealant, dural
Decision date: 2025-02-28
Decision code: APPR
Date received: 2024-09-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order dated July 6, 2023, for P220014