PMA P990046S025
- Device
- MEDTRONIC OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S025
- Product code
- LWQ
- Decision date
- 2011-11-15
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ADDITIONAL SUPPLIER OF DEVICE COMPONENT SUBASSEMBLIES.
Current openFDA PMA Record#
- Device
- MEDTRONIC OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S025
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2011-11-15
- Decision code
- OK30
- Date received
- 2011-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL SUPPLIER OF DEVICE COMPONENT SUBASSEMBLIES.