PMA P830026S073

Device
COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
Applicant
Boston Scientific
PMA number
P830026
Supplement
S073
Product code
LWP
Decision date
1998-08-06
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for modification of the SideLock subsystem.

Current openFDA PMA Record#

Device
COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS
Applicant
Boston Scientific
PMA number
P830026
Supplement
S073
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1998-08-06
Decision code
APPR
Date received
1998-07-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modification of the SideLock subsystem.