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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
2023 eighth st.
berkeley, CA 94710
PMA NumberP870072
Supplement NumberS026
Date Received07/03/2003
Decision Date11/26/2003
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to expand the indications for use to include transport of patients in fixed wing aircraft and in helicopters. This device, as modified, will be marketed under the trade name thoratec paracorporeal ventricular assist device system and tlc-ii portable vad driver. The pvad is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. When used with the tlc-ii portable pneumatic driver, the pvad is intended for use for transportation of vad patients via ground ambulance, fixed wing aircraft or helicopter. In addition, the tlc-ii portable pneumatic driver can be used to allow suitably-qualified patients to take off-site excursions within a two-hour travel radius of the hospital in the company of a trained caregiver.