EVERA S DR, EVERA S VR, EVERA XT DR

FDA premarket approval P980016/S408 · decided 2013-05-03

Approval details

PMA number

P980016

Supplement

S408

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

EVERA S DR, EVERA S VR, EVERA XT DR

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2013-04-08

Decision date

2013-05-03

Days to decision

25 days

Decision code

OK30

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

ADDITION OF A SPECIFIC ACCEPTANCE CRITERION TO ALLOW DELAMINATION FOR THE LOWER WIRE BONDPAD ON THE U31 FET; 2) TWO PROCESS ADJUSTMENT CHANGES FOR THE INTEGRATED CIRCUIT AT MEDTRONIC SUPPLIER3) THE IMPLEMENTATION OF ADDITIONAL TOOLING FOR THE CASE LINER ASSEMBLY MANUFACTURINGPROCESS; 4) A CHANGE TO THE HYBRID CD SURGE MANUFACTURING TEST SOFTWARE; 5) THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT