PMA P100047S015

Device
HEARTWARE VENTRICULAR ASSIST SYSTEM
Applicant
Medtronic
PMA number
P100047
Supplement
S015
Product code
DSQ
Decision date
2013-02-19
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
INSTALLATION OF A NEW LABEL PRINTER.

Current openFDA PMA Record#

Device
HEARTWARE VENTRICULAR ASSIST SYSTEM
Applicant
Medtronic
PMA number
P100047
Supplement
S015
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2013-02-19
Decision code
OK30
Date received
2013-01-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
INSTALLATION OF A NEW LABEL PRINTER.