SUSTAIN XL FAMILY OF PACEMAKERS

FDA premarket approval P880086/S204 · decided 2011-06-08

Approval details

PMA number

P880086

Supplement

S204

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

SUSTAIN XL FAMILY OF PACEMAKERS

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2011-05-06

Decision date

2011-06-08

Days to decision

33 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE NEW SUSTAIN XL PACEMAKER MODELS, PREDICATED OFF THE VICTORY/ZEPHYR FAMILY OF PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUSTAIN XL DR/SR AND SUSTAIN XL DC/SC AND IS INDICATED FOR INDICATIONS AND USAGE: IMPLANTATION OF SUSTAIN PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO:1) SYNCOPE2) PRESYNCOPE3) FATIGUE4) DISORIENTATION5) OR ANY COMBINATION OF THOSE SYMPTOMS.RATE-MO

510(k) clearances by this applicant