PMA P890061S014

Device
VENTAK P
Applicant
Boston Scientific
PMA number
P890061
Supplement
S014
Product code
LWS
Decision date
2004-05-14
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.

Current openFDA PMA Record#

Device
VENTAK P
Applicant
Boston Scientific
PMA number
P890061
Supplement
S014
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2004-05-14
Decision code
OK30
Date received
2004-04-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.