PMA P790018S038
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S038
- Product code
- LWQ
- Decision date
- 2001-12-11
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S038
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2001-12-11
- Decision code
- APPR
- Date received
- 2001-11-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.