FDA.reportPublic FDA data

PMA P060040S077

Device
HeartMate II Left Ventricular Assist System (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S077
Product code
DSQ
Decision date
2020-04-09
Generic name
Ventricular (assist) bypass
Approval order statement
Qualify an alternate sub-supplier for the polyester raw material used in the manufacture of the HeartMate II Apical Sewing Ring and Percutaneous Cable as well as the HeartMate 3 Percutaneous Cable.

Current openFDA PMA Record#

Device
HeartMate II Left Ventricular Assist System (LVAS)
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S077
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2020-04-09
Decision code
OK30
Date received
2020-03-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Qualify an alternate sub-supplier for the polyester raw material used in the manufacture of the HeartMate II Apical Sewing Ring and Percutaneous Cable as well as the HeartMate 3 Percutaneous Cable.