PMA P940031S028

Device: SOFTWARE APPLICATION MODEL 2890 VERSION 4.10
Applicant: Boston Scientific
PMA number: P940031
Supplement: S028
Product code: LWP
Decision date: 2003-10-31
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE SOFTWARE APPLICATIONS FOR THE PULSAR, PULSAR MAX, DISCOVERY, MERIDIAN, CONTAK TR, PULSAR MAX II, AND DISCOVERY II PACEMAKER SYSTEMS.

Current openFDA PMA Record#

Device: SOFTWARE APPLICATION MODEL 2890 VERSION 4.10
Applicant: Boston Scientific
PMA number: P940031
Supplement: S028
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2003-10-31
Decision code: APPR
Date received: 2003-09-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE SOFTWARE APPLICATIONS FOR THE PULSAR, PULSAR MAX, DISCOVERY, MERIDIAN, CONTAK TR, PULSAR MAX II, AND DISCOVERY II PACEMAKER SYSTEMS.