PMA P140018S025

Device
Venaseal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S025
Product code
PJQ
Decision date
2021-05-21
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.

Current openFDA PMA Record#

Device
Venaseal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S025
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2021-05-21
Decision code
APPR
Date received
2021-04-23
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.