MICRONY PACEMAKERS

FDA premarket approval P970013 · decided 2000-12-21

Approval details

PMA number

P970013

Trade name

MICRONY PACEMAKERS

Generic name

Pulse-generator, single chamber, sensor driven, implantable

Applicant

ABBOTT MEDICAL

Date received

1997-01-03

Decision date

2000-12-21

Days to decision

1448 days

Decision code

APPR

Product code

LWO

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE MICRONY(TM) SR+ MODEL 2425T SINGLE CHAMBER RATE ADAPTIVE PULSE GENERATOR, WHICH IS PROGRAMMED WITH THE APS II PROGRAMMER WITH MODLE 3204A SOFTWARE, THE APSU PROGRAMMER, AND THE MODEL 3500/3510 PROGRAMMER WITH MODEL 3304 SOFTWARE. THE DEIVCE IS INDICATED FOR THE FOLLOWING: 1) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMTOMATIC BILAT

510(k) clearances by this applicant