MOMENTUM PACERS
FDA premarket approval P910020/S019 · decided 1997-07-29
Approval details
- PMA number
- P910020
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOMENTUM PACERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1997-06-23
- Decision date
- 1997-07-29
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MOMENTUM PULSE GENERATOR MODELS 294-23, 294-23Z, AND 293-23 WITH RX5000 PROGRAMMER MODEL 522-12 WITH MARATHON APPLICATION SOFTWARE VERSION 3.00
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