PMA P790018S036

Device: MEDTRONIC HALL PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S036
Product code: LWQ
Decision date: 2000-11-09
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN. THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE, MODEL A7700, SIZES 20, 22, AND 24 MM.

Current openFDA PMA Record#

Device: MEDTRONIC HALL PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S036
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2000-11-09
Decision code: OK30
Date received: 2000-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN. THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE, MODEL A7700, SIZES 20, 22, AND 24 MM.