PMA P790018S031
- Device
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S031
- Product code
- LWQ
- Decision date
- 1997-11-24
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for a modification to the controlled environment area for certain manufacturing steps.
Current openFDA PMA Record#
- Device
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S031
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 1997-11-24
- Decision code
- APPR
- Date received
- 1997-07-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a modification to the controlled environment area for certain manufacturing steps.