PMA P140018S021

Device: VenaSeal Closure System
Applicant: Medtronic Vascular, Inc.
PMA number: P140018
Supplement: S021
Product code: PJQ
Decision date: 2021-01-21
Generic name: Agent, occluding, vascular, permanent
Approval order statement: Approval for the supplied HDPE resin and supplier location used for the over molding on the hub of the introducer, dilator and catheter of the VenaSeal delivery system.

Current openFDA PMA Record#

Device: VenaSeal Closure System
Applicant: Medtronic Vascular, Inc.
PMA number: P140018
Supplement: S021
Product code: PJQ
Generic name: Agent, occluding, vascular, permanent
Decision date: 2021-01-21
Decision code: APPR
Date received: 2020-10-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the supplied HDPE resin and supplier location used for the over molding on the hub of the introducer, dilator and catheter of the VenaSeal delivery system.