PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI

FDA premarket approval P030054/S275 · decided 2014-10-21

Approval details

PMA number

P030054

Supplement

S275

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2014-09-26

Decision date

2014-10-21

Days to decision

25 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY.

510(k) clearances by this applicant