PMA P240027S006

Device
SpineSeal Spine Sealant
Applicant
Pramand, LLC
PMA number
P240027
Supplement
S006
Product code
NQR
Decision date
2026-08-31
Classification
Neurology
Generic name
Sealant, dural
Approval order statement
Approval for changes to the device packaging configuration to accommodate previously approved changes to the syringe accessory.

Current openFDA PMA Record#

Device
SpineSeal Spine Sealant
Applicant
Pramand, LLC
PMA number
P240027
Supplement
S006
Product code
NQR
Generic name
Sealant, dural
Decision date
2026-08-31
Decision code
APPR
Date received
2026-06-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the device packaging configuration to accommodate previously approved changes to the syringe accessory.