VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6
FDA premarket approval P960040/S032 · decided 2003-10-22
Approval details
- PMA number
- P960040
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-04-01
- Decision date
- 2003-10-22
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO ENABLE THE AUTOMATIC INTRINSIC RHYTHM ID ALGORITHM UPDATE FEATURE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY VR/DR/VITALITY+ DR AICD SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2857 VERSION 1.6 AND IS INDICATED FOR USE AS FOLLOWS: THE VITALITY VR/DR/VITALITY+ DR AICE SYSTEM IS INDICATED FOR USE IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYT
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