MEDTRONIC(R) THERA(TM) PULSE GENERATORS
FDA premarket approval P890003/S040 · decided 1995-08-15
Approval details
- PMA number
- P890003
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) THERA(TM) PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1995-04-26
- Decision date
- 1995-08-15
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 9877A SOFTWARE DISKETTE WHICH PROVIDES ELECTROPHYSIOLOGY STUDY (EPS) SOFTWARE WITH BACKUP VENTRICULAR PACING
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