TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG
FDA premarket approval P950029/S014 · decided 2001-07-03
Approval details
- PMA number
- P950029
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2001-01-04
- Decision date
- 2001-07-03
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE AUTOTHRESHOLD FEATURE ON TWO TALENT MODEL PACEMAKERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT MODELS DR233 AND SR133 AND IS INDICATED FOR THE FOLLOWING: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK; 2) SY
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