FDA.reportPublic FDA data

PMA P910023S426

Device
Ellipse DR and Ellipse VR
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S426
Product code
LWS
Decision date
2020-03-13
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Alternate supplier of the battery boot component and change to an in-house application of the heat shield tape to the battery boot assembly used in Ellipse DR and VR ICD devices.

Current openFDA PMA Record#

Device
Ellipse DR and Ellipse VR
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S426
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-03-13
Decision code
OK30
Date received
2020-02-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier of the battery boot component and change to an in-house application of the heat shield tape to the battery boot assembly used in Ellipse DR and VR ICD devices.