EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I

FDA premarket approval P980016/S505 · decided 2014-10-16

Approval details

PMA number

P980016

Supplement

S505

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2014-09-19

Decision date

2014-10-16

Days to decision

27 days

Decision code

OK30

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

UPDATES TO THE DISTRIBUTION CENTER SORTER TOOL SYSTEM.