Amplia MRI CRT-D, Quad CRT -D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, MRI Quad CRT-D;

FDA premarket approval P010031/S647 · decided 2018-10-26

Approval details

PMA number

P010031

Supplement

S647

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; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, MRI Quad CRT-D;

Generic name

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

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2018-10-09

Decision date

2018-10-26

Days to decision

17 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Updates at the supplier to the Semi-Automate Feedthrough Inspection.