CADENCE, MODEL V-100
FDA premarket approval P910023/S112 · decided 2006-07-11
Approval details
- PMA number
- P910023
- Supplement
- S112
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE, MODEL V-100
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-06-26
- Decision date
- 2006-07-11
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE.
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