PMA P790018S032

Device: MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S032
Product code: LWQ
Decision date: 1998-07-01
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: Approval to manufacture the sewing ring component of the Medtronic Hall(TM) Prosthetic Heart Valves with knitted polytetrafluoroethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier. The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).

Current openFDA PMA Record#

Device: MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S032
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 1998-07-01
Decision code: APPR
Date received: 1998-01-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to manufacture the sewing ring component of the Medtronic Hall(TM) Prosthetic Heart Valves with knitted polytetrafluoroethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier. The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).