PMA P100047S145
- Device
- HeartWare Left Ventricular Assist Device System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S145
- Product code
- DSQ
- Decision date
- 2019-09-06
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Clarify the process and inspection instructions by including step-by-step instructions for the procedure and dedicated inspection of soldering.
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist Device System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S145
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-09-06
- Decision code
- OK30
- Date received
- 2019-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Clarify the process and inspection instructions by including step-by-step instructions for the procedure and dedicated inspection of soldering.