ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620

FDA premarket approval P880086/S139 · decided 2007-03-29

Approval details

PMA number

P880086

Supplement

S139

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2006-12-11

Decision date

2007-03-29

Days to decision

108 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE ZEPHYR PULSE GENERATORS MODELS: XL DR 5826, DR 5820 AND SR 5620. THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS. RATE MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY. DUAL-CHAMBER PACING (MODELS 58

510(k) clearances by this applicant