BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT-

FDA premarket approval P010031/S445 · decided 2014-05-30

Approval details

PMA number

P010031

Supplement

S445

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT-

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2014-05-08

Decision date

2014-05-30

Days to decision

22 days

Decision code

OK30

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

CHANGE IN THE AVX CAPACITOR LAPPING PROCESS USED IN THE DEVICES.