HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H
FDA premarket approval P910023/S115 · decided 2006-09-18
Approval details
- PMA number
- P910023
- Supplement
- S115
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-08-04
- Decision date
- 2006-09-18
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TO ADD SUPPORT FOR ATLAS II AND EPIC II ICD FAMILIES AND TO REMOVE THE SURFACE ECG FUNCTION.
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