PMA P980023S010

Device: ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S010
Product code: DTA
Decision date: 2002-08-30
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE PCMCIA SOFTWARE CARTRIDGE INCLUDING AN INCREASE IN MEMORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) AND IS INTENDED TO ALLOW INTERROGATION AND PROGRAMMING OF BIOTRONIK ICD'S AND PACEMAKERS.

Current openFDA PMA Record#

Device: ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S010
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2002-08-30
Decision code: APPR
Date received: 2002-07-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE PCMCIA SOFTWARE CARTRIDGE INCLUDING AN INCREASE IN MEMORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) AND IS INTENDED TO ALLOW INTERROGATION AND PROGRAMMING OF BIOTRONIK ICD'S AND PACEMAKERS.