FDA.reportPublic FDA data

PMA P080013S020

Device
DuraSeal Exact Spine Sealant System
Applicant
Integra LifeSciences Corporation
PMA number
P080013
Supplement
S020
Product code
NQR
Decision date
2020-07-22
Generic name
Sealant, dural
Approval order statement
Approval for labeling changes to add additional information on potential risks and adverse events identified in the Summary of Safety and Effectiveness Data for the DuraSeal Exact Spine Sealant System.

Current openFDA PMA Record#

Device
DuraSeal Exact Spine Sealant System
Applicant
Integra LifeSciences Corporation
PMA number
P080013
Supplement
S020
Product code
NQR
Generic name
Sealant, dural
Decision date
2020-07-22
Decision code
APPR
Date received
2020-06-23
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for labeling changes to add additional information on potential risks and adverse events identified in the Summary of Safety and Effectiveness Data for the DuraSeal Exact Spine Sealant System.