PMA P790018S044
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S044
- Product code
- LWQ
- Decision date
- 2003-09-23
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ELIMINATION OF THE PRODUCTION PULSE DUPLICATION TEST FROM THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S044
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2003-09-23
- Decision code
- OK30
- Date received
- 2003-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF THE PRODUCTION PULSE DUPLICATION TEST FROM THE MANUFACTURING PROCESS.