PMA P140018S040

Device: Venaseal Closure System
Applicant: Medtronic Vascular, Inc.
PMA number: P140018
Supplement: S040
Product code: PJQ
Decision date: 2023-10-12
Classification: Cardiovascular
Generic name: Agent, occluding, vascular, permanent
Approval order statement: removal of operators’ hands/gloves testing from the environmental monitoring program for all devices, manufactured at Medtronic Ireland in controlled environment areas meeting ISO Class 8 requirements

Current openFDA PMA Record#

Device: Venaseal Closure System
Applicant: Medtronic Vascular, Inc.
PMA number: P140018
Supplement: S040
Product code: PJQ
Generic name: Agent, occluding, vascular, permanent
Decision date: 2023-10-12
Decision code: OK30
Date received: 2023-09-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of operators’ hands/gloves testing from the environmental monitoring program for all devices, manufactured at Medtronic Ireland in controlled environment areas meeting ISO Class 8 requirements