PMA P910077S058

Device
MINI FAMILY OF IMPLANTABLE PACEMAKERS
Applicant
Boston Scientific
PMA number
P910077
Supplement
S058
Product code
LWS
Decision date
2006-04-26
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.

Current openFDA PMA Record#

Device
MINI FAMILY OF IMPLANTABLE PACEMAKERS
Applicant
Boston Scientific
PMA number
P910077
Supplement
S058
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2006-04-26
Decision code
OK30
Date received
2006-03-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.