PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES

FDA premarket approval P030054/S261 · decided 2014-03-04

Approval details

PMA number

P030054

Supplement

S261

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2014-02-05

Decision date

2014-03-04

Days to decision

27 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.

510(k) clearances by this applicant