CADENCE FAMILY OF ICD'S
FDA premarket approval P910023/S134 · decided 2007-05-07
Approval details
- PMA number
- P910023
- Supplement
- S134
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE FAMILY OF ICD'S
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-04-13
- Decision date
- 2007-05-07
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
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