TELIGEN ICD
FDA premarket approval P960040/S155 · decided 2008-05-08
Approval details
- PMA number
- P960040
- Supplement
- S155
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-12-07
- Decision date
- 2008-05-08
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL
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