PMA P100047S107
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S107
- Product code
- DSQ
- Decision date
- 2017-09-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Relocation of a facility for manufacturing of the HeartWare Ventricular Assist Device (HVAD) AC and DC adapters.
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S107
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-09-13
- Decision code
- OK30
- Date received
- 2017-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of a facility for manufacturing of the HeartWare Ventricular Assist Device (HVAD) AC and DC adapters.