Adapta, Versa, Sensia IPGEnPulse E1 IPG Kappa DR (Kappa 700/600)
FDA premarket approval P980035/S483 · decided 2017-06-09
Approval details
- PMA number
- P980035
- Supplement
- S483
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Adapta, Versa, Sensia IPGEnPulse E1 IPG Kappa DR (Kappa 700/600)
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-11-16
- Decision date
- 2017-06-09
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for hardware, firmware, labeling, and manufacturing changes to support replacing the Bluetooth (BT) Classic module with a BT Low Energy module in the monitor base station.
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