PMA P940031S059

Device: VIGOR/ DISCOVERY/ MERIDIAN/ PULSAR
Applicant: Boston Scientific
PMA number: P940031
Supplement: S059
Product code: LWP
Decision date: 2007-02-08
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.

Current openFDA PMA Record#

Device: VIGOR/ DISCOVERY/ MERIDIAN/ PULSAR
Applicant: Boston Scientific
PMA number: P940031
Supplement: S059
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2007-02-08
Decision code: APPR
Date received: 2006-11-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.