Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262;

FDA premarket approval P030035/S160 · decided 2017-10-16

Approval details

PMA number

P030035

Supplement

S160

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262;

Generic name

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant

ABBOTT MEDICAL

Date received

2017-09-21

Decision date

2017-10-16

Days to decision

25 days

Decision code

OK30

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

Automation of the tray packaging inspection process to ensure the required components are in the tray.

510(k) clearances by this applicant