PMA P970031S019
- Device
- FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S019
- Product code
- LWR
- Decision date
- 2007-11-29
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR THE ADDITION OF A BORATE BUFFERED SALINE (BBS) SOLUTION PRE-RINSE TO THE P5 AMINO-OLEIC ACID (AOA) PROCESS.
Current openFDA PMA Record#
- Device
- FREESTYLE AORTIC ROOT BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S019
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2007-11-29
- Decision code
- APPR
- Date received
- 2007-07-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A BORATE BUFFERED SALINE (BBS) SOLUTION PRE-RINSE TO THE P5 AMINO-OLEIC ACID (AOA) PROCESS.