PMA P100047S040
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S040
- Product code
- DSQ
- Decision date
- 2014-08-25
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR CHANGING THE AC AND DC ADAPTORS OUTPUT CABLING SHEATH AND OVER-MOLD MATERIAL AS WELL AS THE NUMBER OF CONDUCTOR WIRES.
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S040
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-08-25
- Decision code
- APPR
- Date received
- 2014-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE AC AND DC ADAPTORS OUTPUT CABLING SHEATH AND OVER-MOLD MATERIAL AS WELL AS THE NUMBER OF CONDUCTOR WIRES.