PMA P790018S034

Device: MEDTRONIC HALL PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S034
Product code: LWQ
Decision date: 1998-11-16
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: The 30-day notice requested a change in the supplier of a raw material (yarn) for the device because the current supplier of Polytetrafluoroethylene (PTFE) yarn has chosen to withdraw this material from the implantable medical device industry.

Current openFDA PMA Record#

Device: MEDTRONIC HALL PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S034
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 1998-11-16
Decision code: OK30
Date received: 1998-10-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day notice requested a change in the supplier of a raw material (yarn) for the device because the current supplier of Polytetrafluoroethylene (PTFE) yarn has chosen to withdraw this material from the implantable medical device industry.