VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812
FDA premarket approval P960040/S029 · decided 2003-03-26
Approval details
- PMA number
- P960040
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2002-09-03
- Decision date
- 2003-03-26
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF ATRIAL ARRHYTHMIA THERAPIES TO THE VITALITY AICD SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY AVT AND PROGRAMMER SOFTWARE APPLICATION MODEL 2812, AND IS INDICATED FOR USE IN THE FOLLOWING: 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: 1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.