PMA P870072S005
- Device
- THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S005
- Product code
- DSQ
- Decision date
- 1998-05-21
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the Thoratec(R) Ventricular Assist Device (VAD) System. This device is now also indicated for post-cardiotomy patients who are unable to be weaned from cardiopulmonary bypass.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P870072S005B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S005
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1998-05-21
- Decision code
- APPR
- Date received
- 1997-10-06
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Thoratec(R) Ventricular Assist Device (VAD) System. This device is now also indicated for post-cardiotomy patients who are unable to be weaned from cardiopulmonary bypass.