FDA.reportPublic FDA data

PMA P980035S618

Device
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
Applicant
Medtronic, Inc.
Product code
NVZ
Decision date
2020-05-08
Generic name
Pulse generator, permanent, implantable
Approval order statement
Approval for RAMware updates to ICD, CRT-D, CRT-P, and IPG devices and corresponding updates to Medtronic CareLink Programmer Model 2090 and Encore Programmer Model 29901 device applications SW034, SW035, SW030, and SW040.

Current openFDA PMA Record#

Device
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S618
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2020-05-08
Decision code
APPR
Date received
2020-02-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for RAMware updates to ICD, CRT-D, CRT-P, and IPG devices and corresponding updates to Medtronic CareLink Programmer Model 2090 and Encore Programmer Model 29901 device applications SW034, SW035, SW030, and SW040.