PMA P830026S076

Device: RX5000 PROGRAMMER
Applicant: Boston Scientific
PMA number: P830026
Supplement: S076
Product code: LWP
Decision date: 1999-10-29
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for a modification to the as shipped configuration for refurbished and repaired Rx5000 Pacemaker Programmers. Specifically, to offer the Triangular Chest Lead Cable Model 526-04 as a purchasable accessory and no longer include it with the shipped units.

Current openFDA PMA Record#

Device: RX5000 PROGRAMMER
Applicant: Boston Scientific
PMA number: P830026
Supplement: S076
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1999-10-29
Decision code: APPR
Date received: 1999-10-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a modification to the as shipped configuration for refurbished and repaired Rx5000 Pacemaker Programmers. Specifically, to offer the Triangular Chest Lead Cable Model 526-04 as a purchasable accessory and no longer include it with the shipped units.