MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM
FDA premarket approval P980035/S014 · decided 2001-12-14
Approval details
- PMA number
- P980035
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2001-10-24
- Decision date
- 2001-12-14
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC KAPPA 900/800 PACEMAKER SERIES MODELS K(DR)901, K(DR)903, K(DR)906, K(DR)921, K(DR)931, K(DR)933, K(DR)801, K(DR)803, K(DR)806, K(D)901, K(D)903, K(D)906, KVDD901, KSR901, KSR903, AND KSR906 AND MODEL 9988 SOFTWARE SERIES 1.1. THE DEVICES ARE INDICATED FOR THE FOLLOWING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. 2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: A)
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