PMA P140018S017

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S017
Product code
PJQ
Decision date
2019-12-20
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Approval for a change to the de-nesting coating agent added to the polyethylene terephthalate glycol (PET-G) film component of the packaging.

Current openFDA PMA Record#

Device
VenaSeal Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S017
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2019-12-20
Decision code
APPR
Date received
2019-09-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the de-nesting coating agent added to the polyethylene terephthalate glycol (PET-G) film component of the packaging.