PMA P990046S019
- Device
- OPEN PIVOT BI-LEAFLET HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S019
- Product code
- LWQ
- Decision date
- 2009-04-24
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- OPEN PIVOT BI-LEAFLET HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S019
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2009-04-24
- Decision code
- APPR
- Date received
- 2008-09-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.