PMA P140018S042

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S042
Product code
PJQ
Decision date
2024-05-08
Classification
Cardiovascular
Generic name
Agent, occluding, vascular, permanent
Approval order statement
a reduction of cleanroom environmental monitoring testing locations

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S042
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2024-05-08
Decision code
OK30
Date received
2024-04-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a reduction of cleanroom environmental monitoring testing locations