PMA P830026S074

Device: RX 7000 PROGRAMMING SYSTEM
Applicant: Boston Scientific
PMA number: P830026
Supplement: S074
Product code: LWP
Decision date: 1999-02-18
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software. The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators.

Current openFDA PMA Record#

Device: RX 7000 PROGRAMMING SYSTEM
Applicant: Boston Scientific
PMA number: P830026
Supplement: S074
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1999-02-18
Decision code: APPR
Date received: 1998-10-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software. The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators.