PMA P970031S048
- Device
- FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS)
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S048
- Product code
- LWR
- Decision date
- 2014-11-12
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
Current openFDA PMA Record#
- Device
- FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS)
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S048
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2014-11-12
- Decision code
- OK30
- Date received
- 2014-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.