MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE
FDA premarket approval P970012/S010 · decided 2001-03-08
Approval details
- PMA number
- P970012
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2001-02-08
- Decision date
- 2001-03-08
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE KAPPA 650 SERIES PULSE GENERATORS AND VISION SOFTWARE SERIES 4.0.
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