VITATRON DIVA IMPLANTABLE PULSE GENERATORS

FDA premarket approval P990001/S002 · decided 1999-11-12

Approval details

PMA number

P990001

Supplement

S002

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VITATRON DIVA IMPLANTABLE PULSE GENERATORS

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

1999-10-12

Decision date

1999-11-12

Days to decision

31 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

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 feedthro

510(k) clearances by this applicant