PMA P990046S049
- Device
- Open Pivot Heart Valve, Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S049
- Product code
- LWQ
- Decision date
- 2017-08-22
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- implementation of a continuous monitoring system for controlled environment areas
Current openFDA PMA Record#
- Device
- Open Pivot Heart Valve, Open Pivot Aortic Valved Graft
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S049
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2017-08-22
- Decision code
- OK30
- Date received
- 2017-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a continuous monitoring system for controlled environment areas