PMA P790018S041

Device: MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S041
Product code: LWQ
Decision date: 2002-04-23
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL FOR A CHANGE TO THE COUNTRY OF ORIGIN FOR THE COLLAGEN USED IN THESE PRODUCTS. THE INTENT OF THE CHANGE IS TO SOURCE THE COLLAGEN FROM A COUNTRY THAT IS FREE FROM BOVINE SPONGIFORM ENCEPHALOPATHY (BSE).

Current openFDA PMA Record#

Device: MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S041
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2002-04-23
Decision code: APPR
Date received: 2001-11-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE COUNTRY OF ORIGIN FOR THE COLLAGEN USED IN THESE PRODUCTS. THE INTENT OF THE CHANGE IS TO SOURCE THE COLLAGEN FROM A COUNTRY THAT IS FREE FROM BOVINE SPONGIFORM ENCEPHALOPATHY (BSE).