MEDTRONIC KAPPA 900/800 PACEMAKER SERIES
FDA premarket approval P980035/S019 · decided 2003-08-07
Approval details
- PMA number
- P980035
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC KAPPA 900/800 PACEMAKER SERIES
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2002-01-24
- Decision date
- 2003-08-07
- Days to decision
- 560 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR EXPANDED PROGRAMMABLE UPPER TRACKING RATE OPTIONS AND POST MODE SWITCH OVERDRIVE PACING.
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