PMA P970031S017
- Device
- FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S017
- Product code
- LWR
- Decision date
- 2006-09-01
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- CHANGE TO THE SUPPLIER OF THE PLOYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
Current openFDA PMA Record#
- Device
- FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S017
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2006-09-01
- Decision code
- OK30
- Date received
- 2006-08-03
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE SUPPLIER OF THE PLOYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.