Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M

FDA premarket approval P980016/S691 · decided 2018-10-24

Approval details

PMA number

P980016

Supplement

S691

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2018-10-15

Decision date

2018-10-24

Days to decision

9 days

Decision code

OK30

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Change the stacked chip scale to convert from halogenated to halogen-free.