Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT-

FDA premarket approval P010031/S562 · decided 2016-10-24

Approval details

PMA number

P010031

Supplement

S562

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT-

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2016-09-26

Decision date

2016-10-24

Days to decision

28 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Extension of a continuous monitoring system for non-controlled manufacturing areas.