PMA P990046S029
- Device
- MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S029
- Product code
- LWQ
- Decision date
- 2012-06-25
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S029
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-06-25
- Decision code
- APPR
- Date received
- 2012-04-26
- 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.