EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR

FDA premarket approval P980016/S410 · decided 2013-05-07

Approval details

PMA number

P980016

Supplement

S410

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2013-04-09

Decision date

2013-05-07

Days to decision

28 days

Decision code

OK30

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

SEVEN PREVIOUSLY APPROVED MANUFACTURE CHANGES FOR THE DEVICES. THOSE ARE:1) UPDATE THE CMOS IC PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATE THE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 ICS;3) ADD THE HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE; 4) UPDATE THE AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER (AAEC); 5) IMPLEMENT A NEW CLEANING PROCESS AND A CURING OVEN; 6) IMPLEMENT A MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FIN