PMA P970031S034
- Device
- FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S034
- Product code
- LWR
- Decision date
- 2011-08-25
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- ADDITION OF A GLUTARALDEHYDE SUPPLIER.
Current openFDA PMA Record#
- Device
- FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S034
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2011-08-25
- Decision code
- OK30
- Date received
- 2011-07-28
- Supplement type
- 30-Day Notice
- Approval order statement
- ADDITION OF A GLUTARALDEHYDE SUPPLIER.