ADVISA MRI

FDA premarket approval P980035/S318 · decided 2013-05-07

Approval details

PMA number

P980035

Supplement

S318

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ADVISA MRI

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2013-04-09

Decision date

2013-05-07

Days to decision

28 days

Decision code

OK30

Product code

NVZ

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

510(k) clearances by this applicant