VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2
FDA premarket approval P960040/S035 · decided 2003-10-06
Approval details
- PMA number
- P960040
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-09-11
- Decision date
- 2003-10-06
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A FAST-CHARGE VERSION OF THE DEVICE (MODEL A155) AND TO CORRECT SOFTWARE ANOMALIES (MODELS A155 AND A135). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VENTAK VITALITY AVT AICD SYSTEM AND IS INDICATED AS FOLLOWS: THE VITALITY AVT AICD SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE THOSE WHO HAV
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