LEGEND II MODELS 8424,8426,8427 AND 8430 PULSE G.
FDA premarket approval P850051/S032 · decided 1991-11-25
Approval details
- PMA number
- P850051
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEGEND II MODELS 8424,8426,8427 AND 8430 PULSE G.
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 1991-05-30
- Decision date
- 1991-11-25
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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