PMA P790018S049
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S049
- Product code
- LWQ
- Decision date
- 2008-09-09
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- CHANGE IN VENDOR FOR A SUTURE USED IN THE MANUFACTURE OF THE DEVICES.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S049
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2008-09-09
- Decision code
- OK30
- Date received
- 2008-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN VENDOR FOR A SUTURE USED IN THE MANUFACTURE OF THE DEVICES.