VITALITY DS ICD SYSTEMS
FDA premarket approval P960040/S031 · decided 2003-07-10
Approval details
- PMA number
- P960040
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITALITY DS ICD SYSTEMS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-03-17
- Decision date
- 2003-07-10
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6, AND THE INDICATION FOR USE IS AS FOLLOWS:G
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