MODEL 2920 (PRM) SYSTEM ZOOM (VIGOR DR/SR PACEMAKER SYSTEM)
FDA premarket approval P940031/S023 · decided 2000-05-18
Approval details
- PMA number
- P940031
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2920 (PRM) SYSTEM ZOOM (VIGOR DR/SR PACEMAKER SYSTEM)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-12-20
- Decision date
- 2000-05-18
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the Model 2920 ZOOM Programming System.
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