PMA P140018S016

Device: VenaSeal Closure System
Applicant: Medtronic Vascular, Inc.
PMA number: P140018
Supplement: S016
Product code: PJQ
Decision date: 2019-08-12
Classification: Agent, Occluding, Vascular, Permanent
Generic name: Agent, occluding, vascular, permanent
Approval order statement: Implementation of a new dishwasher and water purification system in the shared glassware cleaning area within the Medtronic Ireland manufacturing facility.

Current openFDA PMA Record#

Device: VenaSeal Closure System
Applicant: Medtronic Vascular, Inc.
PMA number: P140018
Supplement: S016
Product code: PJQ
Generic name: Agent, occluding, vascular, permanent
Decision date: 2019-08-12
Decision code: OK30
Date received: 2019-08-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new dishwasher and water purification system in the shared glassware cleaning area within the Medtronic Ireland manufacturing facility.