KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2
FDA premarket approval P980035/S044 · decided 2005-07-26
Approval details
- PMA number
- P980035
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2005-07-11
- Decision date
- 2005-07-26
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS TO THE IPG REED SWITCH.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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