PMA P990001S002

Device: VITATRON DIVA IMPLANTABLE PULSE GENERATORS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S002
Product code: DXY
Decision date: 1999-11-12
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for modifications to the Diva family implantable pulse generator: adding the following new models: Diamond II Model 820E; Ruby II Model 720E; Topaz II Model 520E; Jade II Model 220E; vita DDDr Model 810E; Vita DDD Model 710E; Vita VVIR Model 310E. Introduction of 3.2mm models the Diamond II Model 822E and Topaz II Model 522E; modifying the programmer software to recognize the new model numbers; modifying the header to be consistent with the Medtronic Kappa 400; move to mulitple feedthroughs from a single feedthrough design; change the tissue contracting materials and packaging to those currently used in Medtronic's Kappa 400; and modify the labeling to accommoate the additional models and attendant software changes.

Current openFDA PMA Record

Device: VITATRON DIVA IMPLANTABLE PULSE GENERATORS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S002
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1999-11-12
Decision code: APPR
Date received: 1999-10-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modifications to the Diva family implantable pulse generator: adding the following new models: Diamond II Model 820E; Ruby II Model 720E; Topaz II Model 520E; Jade II Model 220E; vita DDDr Model 810E; Vita DDD Model 710E; Vita VVIR Model 310E. Introduction of 3.2mm models the Diamond II Model 822E and Topaz II Model 522E; modifying the programmer software to recognize the new model numbers; modifying the header to be consistent with the Medtronic Kappa 400; move to mulitple feedthroughs from a single feedthrough design; change the tissue contracting materials and packaging to those currently used in Medtronic's Kappa 400; and modify the labeling to accommoate the additional models and attendant software changes.