PMA P140018

Device
VenaSealâ„¢ Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S036
Product code
PJQ
Decision date
2026-04-17
Generic name
Agent, occluding, vascular, permanent
Approval order statement
an alternate primary biological indicator for use in the dry heat sterilization process

Current openFDA PMA Record#

Device
VenaSealâ„¢ Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S049
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2026-04-17
Decision code
OK30
Date received
2026-03-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an alternate primary biological indicator for use in the dry heat sterilization process