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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.
 
Trade NameTCI HEARTMATE 1000A IP LVAS
Classification Nameventricular (assisst) bypass
Generic Nameleft ventricular assist device
ApplicantTHERMO CARDIOSYSTEMS, INC.
PMA NumberP920014
Supplement NumberS011
Date Received05/15/2000
Decision Date07/20/2000
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the protocol to be used to extend the shelf life from 2 years to 3 years for products that are ethylene oxide (eo) sterilized per specification 24215 rev g in the following types of packaging: blister tray 0. 040" petg with tyvek 1073b lid (coated one side with adhesive) and tyvek pouches (inner and outer pouches) made with 1073b tyvek, sealed to 48 ga petg/2. 0 mil polyethylene.
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