HOUSECALL PLUS SYSTEM
FDA premarket approval P910023/S131 · decided 2007-04-17
Approval details
- PMA number
- P910023
- Supplement
- S131
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HOUSECALL PLUS SYSTEM
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-02-21
- Decision date
- 2007-04-17
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM, MERLIN.NET V2.0, WHICH WILL ALLOW THE PHYSICIAN TO VIEW CURRENTLY AVAILABLE WEB PORTAL. IN ADDITION, THE RECEIVER SOFTWARE HAS BEEN MODIFIED TO IMPROVE THE COMMUNICATION EFFICIENCY.
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