HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1)
FDA premarket approval P910023/S078 · decided 2005-05-24
Approval details
- PMA number
- P910023
- Supplement
- S078
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-04-14
- Decision date
- 2005-05-24
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.1).
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