3500/3510 PROGRAMMER
FDA premarket approval P880086/S067 · decided 2000-01-28
Approval details
- PMA number
- P880086
- Supplement
- S067
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 3500/3510 PROGRAMMER
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-07-22
- Decision date
- 2000-01-28
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval is for the Model 3304 Programmer Software for use with the Model 3500 and 3510 Programmers. The device is indicated for programming and interrogation of implanted St. Jude pacemakers.
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