Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Cobalt HF CRT-

FDA premarket approval P010031/S701 · decided 2020-05-27

Approval details

PMA number

P010031

Supplement

S701

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Cobalt HF CRT-

Generic name

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

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2020-04-29

Decision date

2020-05-27

Days to decision

28 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Implement previously approved changes for the Cobalt/Chrome device family.