CARDIAC PACEMAKER PROGRAMMER & BASE STATION
FDA premarket approval P880086/S068 · decided 1999-09-24
Approval details
- PMA number
- P880086
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARDIAC PACEMAKER PROGRAMMER & BASE STATION
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-09-07
- Decision date
- 1999-09-24
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSu Programmer.
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