PMA P100047S070
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S070
- Product code
- DSQ
- Decision date
- 2016-02-09
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for process changes at the internal battery supplier for HVAD controller.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S070
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-02-09
- Decision code
- APPR
- Date received
- 2015-11-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for process changes at the internal battery supplier for HVAD controller.