PMA P990046S032
- Device
- OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S032
- Product code
- LWQ
- Decision date
- 2013-06-07
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MINNEAPOLIS,MINNESOTA.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S032
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2013-06-07
- Decision code
- APPR
- Date received
- 2013-03-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MINNEAPOLIS,MINNESOTA.