PMA P910077S036

Device
VENTAK MINI IV (AICD)
Applicant
Boston Scientific
PMA number
P910077
Supplement
S036
Product code
LWS
Decision date
2001-01-23
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE MODEL 6942 BI-DIRECTIONAL TORQUE WRENCH.

Current openFDA PMA Record#

Device
VENTAK MINI IV (AICD)
Applicant
Boston Scientific
PMA number
P910077
Supplement
S036
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2001-01-23
Decision code
APPR
Date received
2000-12-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE MODEL 6942 BI-DIRECTIONAL TORQUE WRENCH.