MARATHON PACING SYSYTEM
FDA premarket approval P910020/S016 · decided 1996-10-16
Approval details
- PMA number
- P910020
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARATHON PACING SYSYTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1996-04-19
- Decision date
- 1996-10-16
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE RX5000 VERSION 2.00.01 SOFTWARE FOR USE WITH THE RX5000 MODEL 522-12 PROGRAMMER TO PROGRAM THE MARATHON PACING SYSTEM.
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