BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D

FDA premarket approval P010031/S371 · decided 2013-05-07

Approval details

PMA number

P010031

Supplement

S371

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2013-04-09

Decision date

2013-05-07

Days to decision

28 days

Decision code

OK30

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