PMA P790018
- Device
- HALL EASY-FIT PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S051
- Product code
- LWQ
- Decision date
- 2009-12-18
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR LABELING CHANGES.
Current openFDA PMA Record#
- Device
- HALL EASY-FIT PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S051
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2009-12-18
- Decision code
- APPR
- Date received
- 2009-02-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES.