PMA P840068S034

Device: DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
Applicant: Boston Scientific
PMA number: P840068
Supplement: S034
Product code: LWP
Decision date: 1998-03-27
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.

Current openFDA PMA Record#

Device: DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
Applicant: Boston Scientific
PMA number: P840068
Supplement: S034
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1998-03-27
Decision code: APPR
Date received: 1998-03-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.