INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS
FDA premarket approval P960040/S235 · decided 2011-11-17
Approval details
- PMA number
- P960040
- Supplement
- S235
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-08-30
- Decision date
- 2011-11-17
- Days to decision
- 444 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR INCEPTA, ENERGEN. PUNCTUA AND TELIGEN ICD MODELS AND THE INCEPTA, ENERGEN. PUNCTUA AND COGNIS CRT-D MODELS AND PRM SOFTWARE APPLICATION MODEL 2868 AND PULSE GENERATOR SOFTWARE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD AND CRT-D MODELS AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIASOR FOR PATIE
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