PMA P990046S069
- Device
- Open Pivot heart valve
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S069
- Product code
- LWQ
- Decision date
- 2023-11-07
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- two new Coordinate Measuring Machines (CMM) for measuring the orifice components
Current openFDA PMA Record#
- Device
- Open Pivot heart valve
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S069
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-11-07
- Decision code
- OK30
- Date received
- 2023-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- two new Coordinate Measuring Machines (CMM) for measuring the orifice components