PMA P850051S055

Device: 8085 PREVAIL IMPLANTABLE PULSE GENERATOR
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S055
Product code: LWO
Decision date: 2000-07-21
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Approval order statement: APPROVAL FOR THE USE OF HEADER PART NUMBER 149422-002 IN THE FOLLOWING PULSE GENERATORS: PREVAIL MODEL 8085, PREVA SR MODEL 8089, PRODIGY S MODEL 8165, PRODIGY SR MODEL 8161, THERA-I S MODEL 8965I, THERA-I SR MODEL 8961I, VITATRON VISA S MODEL 115 AND VITATRON VISA SR MODEL 415.

Current openFDA PMA Record

Device: 8085 PREVAIL IMPLANTABLE PULSE GENERATOR
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S055
Product code: LWO
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Decision date: 2000-07-21
Decision code: APPR
Date received: 2000-06-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF HEADER PART NUMBER 149422-002 IN THE FOLLOWING PULSE GENERATORS: PREVAIL MODEL 8085, PREVA SR MODEL 8089, PRODIGY S MODEL 8165, PRODIGY SR MODEL 8161, THERA-I S MODEL 8965I, THERA-I SR MODEL 8961I, VITATRON VISA S MODEL 115 AND VITATRON VISA SR MODEL 415.