PMA P970031S003
- Device
- MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S003
- Product code
- LWR
- Decision date
- 1998-06-16
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for the patient brochure for the device.
Current openFDA PMA Record#
- Device
- MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S003
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 1998-06-16
- Decision code
- APPR
- Date received
- 1997-12-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the patient brochure for the device.