PMA P990046S016
- Device
- OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S016
- Product code
- LWQ
- Decision date
- 2007-12-11
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE MODELS AP360.
Current openFDA PMA Record#
- Device
- OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S016
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2007-12-11
- Decision code
- APPR
- Date received
- 2006-12-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE MODELS AP360.