MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO
FDA premarket approval P890003/S014 · decided 1992-04-10
Approval details
- PMA number
- P890003
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1992-03-26
- Decision date
- 1992-04-10
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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