MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

FDA premarket approval P980035/S013 · decided 2003-03-26

Approval details

PMA number

P980035

Supplement

S013

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2001-09-17

Decision date

2003-03-26

Days to decision

555 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE. THE MEDTRONIC AT500 DDDRP PACING SYSTEM IS INDICATED FOR THE FOLLOWING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. 2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: A)SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK. B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK. C) SYMPTOMATIC PAROX

510(k) clearances by this applicant