PMA P850051S051

Device: MEDTRONIC SINGLE CHAMBER PACEMAKERS
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S051
Product code: LWO
Decision date: 1995-10-31
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Approval order statement: APPROVAL FOR THE ADDITION OF THREE MODELS OF PULSE GENERATORS TO YOUR ACTIVITRAX CARDIAC PACING SYSTEM. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAEM OF PREVAIL (MODELS 8084, 8085, AND 8086) USING MODEL 9885E SOFTWARE WITH THE ALREADY APPROVED PROGRAMMERS MODELS 9760 AND 9790, AND MOMORYMOD MODEL 9773 FOR USE WITH THE ALREADY APPROVED MODEL 9710A PROGRAMMER.

Current openFDA PMA Record

Device: MEDTRONIC SINGLE CHAMBER PACEMAKERS
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S051
Product code: LWO
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Decision date: 1995-10-31
Decision code: APPR
Date received: 1995-07-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THREE MODELS OF PULSE GENERATORS TO YOUR ACTIVITRAX CARDIAC PACING SYSTEM. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAEM OF PREVAIL (MODELS 8084, 8085, AND 8086) USING MODEL 9885E SOFTWARE WITH THE ALREADY APPROVED PROGRAMMERS MODELS 9760 AND 9790, AND MOMORYMOD MODEL 9773 FOR USE WITH THE ALREADY APPROVED MODEL 9710A PROGRAMMER.