CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S207 · decided 2009-04-30
Approval details
- PMA number
- P910023
- Supplement
- S207
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-04-08
- Decision date
- 2009-04-30
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR ENHANCEMENTS TO THE SOFTWARE (VERSION 4.0) USED IN THE ST. JUDE MEDICAL MERLIN.NET SYSTEM.
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