ADVISA SR MRI

FDA premarket approval P980035/S418 · decided 2015-04-21

Approval details

PMA number

P980035

Supplement

S418

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ADVISA SR MRI

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2015-03-24

Decision date

2015-04-21

Days to decision

28 days

Decision code

OK30

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

FOURTEEN (14) MANUFACTURING CHANGES FOR ADVISA SR MRI THAT HAD BEEN PREVIOUSLY REVIEWED AND ACCEPTED TO ALIGN THE ADVISA SR MRI MANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) TOOLING CHANGES AND ALTERNATE SUPPLIER FOR FT INSULATOR; 2) MANUFACTURING PROCESS CHANGE FOR PRINTED WIRING BOARD SUBSTRATES; 3) LEAK CHECK TESTER WITH SOFTWARE UPDATES; 4) NEW MATERIAL SUPPLIER AND SPECIFICATION UPDATE FOR P(ETFE); 5) PLASMA CLEANING PROCESS CHANGE; 6) FACTORYWORKS RELEASE 7.1

510(k) clearances by this applicant