SYNCHRONY MODEL 2020T PULSE GENERATOR
FDA premarket approval P880086/S097 · decided 2003-10-31
Approval details
- PMA number
- P880086
- Supplement
- S097
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHRONY MODEL 2020T PULSE GENERATOR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2003-10-07
- Decision date
- 2003-10-31
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE MODEL 3510 PROGRAMMER PLATFORM BY ADDING A VIDEO DISPLAY OUT PORT AND THE ADDITION OF A NEW VIDEO CABLE, MODEL 3134.
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