CADENCE ICD SYSTEM
FDA premarket approval P910023/S233 · decided 2010-07-09
Approval details
- PMA number
- P910023
- Supplement
- S233
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE ICD SYSTEM
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-05-19
- Decision date
- 2010-07-09
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR SOFTWARE VERSION 4.6 FOR THE MERLIN.NET SYSTEM AND MERLIN@HOME MODEL EX2000 VERSION 4.6 SOFTWARE FOR THE MERLIN@HOME DEVICES.
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