PMA P790018S040
- Device
- MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S040
- Product code
- LWQ
- Decision date
- 2001-12-19
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- ADDITION OF AN ALTERNATE STEAM (AUTOCLAVE) STERILIZER WITH A CHANGE IN STERILIZATION TIME FROM 24 TO 40 MINUTES.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S040
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2001-12-19
- Decision code
- OK30
- Date received
- 2001-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE STEAM (AUTOCLAVE) STERILIZER WITH A CHANGE IN STERILIZATION TIME FROM 24 TO 40 MINUTES.