PMA P870072S001
- Device
- THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S001
- Product code
- DSQ
- Decision date
- 1996-07-10
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR ADDING REFERENCES TO THE DIRECTIONS FOR USE FOR THE THORATEC VAD SYSTEM
Current openFDA PMA Record#
- Device
- THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S001
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1996-07-10
- Decision code
- APPR
- Date received
- 1996-01-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDING REFERENCES TO THE DIRECTIONS FOR USE FOR THE THORATEC VAD SYSTEM