PMA P990046S030
- Device
- OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S030
- Product code
- LWQ
- Decision date
- 2012-11-20
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ADDITION OF A DUAL CHAMBER COATER.
Current openFDA PMA Record#
- Device
- OPEN PIVOT HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S030
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-11-20
- Decision code
- OK30
- Date received
- 2012-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A DUAL CHAMBER COATER.