MARATHON PACING SYSYTEM
FDA premarket approval P910020/S017 · decided 1997-02-10
Approval details
- PMA number
- P910020
- Supplement
- S017
- 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
- 1996-08-05
- Decision date
- 1997-02-10
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MARATHON DR AND SR PULSE GENERATORS, GRAPHICS PROGRAM MODULE MODEL 570-01, AND TO THE RELEASE 2.00 SOFTWARE FOR USE WITH THE RX5000 GRAPHICS PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MARATHON Z PULSE GENERATOR MAODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LO
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