PMA P790018S046
- Device
- MEDTRONIC HALL
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S046
- Product code
- LWQ
- Decision date
- 2006-11-07
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S046
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2006-11-07
- Decision code
- APPR
- Date received
- 2006-05-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.