PMA P990001S112

Device: VITATRON C20 SR IPG , C60 DR IPG, T20 SR IPG, VITATRON T60 DR IPG
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S112
Product code: NVZ
Decision date: 2013-07-23
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.

Current openFDA PMA Record

Device: VITATRON C20 SR IPG , C60 DR IPG, T20 SR IPG, VITATRON T60 DR IPG
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S112
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2013-07-23
Decision code: APPR
Date received: 2013-05-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.