PMA P870072S021
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S021
- Product code
- DSQ
- Decision date
- 2003-05-14
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE USE OF A REVERSE-ENGINEERED DIRECTIONAL FLOW VALVE, TO BE MANUFACTURED AT THE SITE LOCATED IN PLEASANTON, CALIFORNIA.
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S021
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2003-05-14
- Decision code
- APPR
- Date received
- 2002-09-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF A REVERSE-ENGINEERED DIRECTIONAL FLOW VALVE, TO BE MANUFACTURED AT THE SITE LOCATED IN PLEASANTON, CALIFORNIA.