ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS
FDA premarket approval P910023/S126 · decided 2006-12-13
Approval details
- PMA number
- P910023
- Supplement
- S126
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-11-21
- Decision date
- 2006-12-13
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT.
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510(k) clearances by this applicant
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