MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66
FDA premarket approval P910020/S013 · decided 1996-05-03
Approval details
- PMA number
- P910020
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1995-12-14
- Decision date
- 1996-05-03
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66 GRAPHICS PROGRAM MODULE. THE MARATHON FAMILY OF PULSE GENERATORS CONSISTS OF THE FOLLOWING MODELS: - MARATHON DR MODELS 294-09, 293-09, 294-09R, 294-10; MARATHON SR MODELS 292-09, 291-09, 292-09R, 292-10, 292-09X; COSMOS 3 MODELS 283-09, 284-09, 284-09R
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