PMA P910023S104

Device
EPIC II, EPIC II+, EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILATORS
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S104
Product code
LWS
Decision date
2006-04-28
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.

Current openFDA PMA Record#

Device
EPIC II, EPIC II+, EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILATORS
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S104
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2006-04-28
Decision code
APPR
Date received
2006-03-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.