PMA P910077S129

Device
VENTAK PRX AND VENTAK MINI ICD FANILIES
Applicant
Boston Scientific
PMA number
P910077
Supplement
S129
Product code
LWS
Decision date
2012-12-05
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
REPLACE THE TRACEABILITY AND TRACKING SYSTEM.

Current openFDA PMA Record#

Device
VENTAK PRX AND VENTAK MINI ICD FANILIES
Applicant
Boston Scientific
PMA number
P910077
Supplement
S129
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2012-12-05
Decision code
OK30
Date received
2012-11-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REPLACE THE TRACEABILITY AND TRACKING SYSTEM.