PMA P140018S047

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S047
Product code
PJQ
Decision date
2025-09-26
Classification
Cardiovascular
Generic name
Agent, occluding, vascular, permanent
Approval order statement
the introduction of a camera-based vision system at Harmac Medical to scan the UDI-compliant barcodes

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S047
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2025-09-26
Decision code
OK30
Date received
2025-09-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the introduction of a camera-based vision system at Harmac Medical to scan the UDI-compliant barcodes