PMA P830026S064

Device
COSMOS FAMILY OF PULSE GENERATORS
Applicant
Boston Scientific
PMA number
P830026
Supplement
S064
Product code
LWP
Decision date
1996-04-01
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
ALTERNATE STERILIZATION PROCESS

Current openFDA PMA Record#

Device
COSMOS FAMILY OF PULSE GENERATORS
Applicant
Boston Scientific
PMA number
P830026
Supplement
S064
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1996-04-01
Decision code
APPR
Date received
1995-09-18
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE STERILIZATION PROCESS