PMA P950037S015

Device: PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S015
Product code: DTB
Decision date: 2000-09-05
Classification: Permanent Pacemaker Electrode
Generic name: permanent pacemaker Electrode
Approval order statement: APPROVAL FOR THE ACTIVATION OF THE PMT MANAGEMENT AND AV DELAY FEATURES IN THE PHILOS PULSE GENERATOR FAMILY, MODIFICATIONS TO THE PROGRAMMER SOFTWARE RESULTING IN VERSION B-K01.0.U, THE PGH 3000 PROGRAMMER HEAD, AND THE VK-92 PROGRAMMER PRINTER CABLE.

Current openFDA PMA Record#

Device: PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S015
Product code: DTB
Generic name: permanent pacemaker Electrode
Decision date: 2000-09-05
Decision code: APPR
Date received: 2000-08-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ACTIVATION OF THE PMT MANAGEMENT AND AV DELAY FEATURES IN THE PHILOS PULSE GENERATOR FAMILY, MODIFICATIONS TO THE PROGRAMMER SOFTWARE RESULTING IN VERSION B-K01.0.U, THE PGH 3000 PROGRAMMER HEAD, AND THE VK-92 PROGRAMMER PRINTER CABLE.