PMA P970031S007

Device: MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S007
Product code: LWR
Decision date: 1998-10-30
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: The 30-day Notice requested a change in the method in which a raw material (AOA compound) is synthesized. This will result in the raw material being received in a more purified form. The quality control test performed in incoming inspection will change from the Gravimetric test method to the Ninhydrin test method.

Current openFDA PMA Record#

Device: MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S007
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 1998-10-30
Decision code: OK30
Date received: 1998-10-02
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 method in which a raw material (AOA compound) is synthesized. This will result in the raw material being received in a more purified form. The quality control test performed in incoming inspection will change from the Gravimetric test method to the Ninhydrin test method.