Medtronic CareLink Model 9986 (2090 CareLink Programmer), Model SW028 (29901 Encore Programmer)
FDA premarket approval P890003/S396 · decided 2018-11-21
Approval details
- PMA number
- P890003
- Supplement
- S396
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Medtronic CareLink Model 9986 (2090 CareLink Programmer), Model SW028 (29901 Encore Programmer)
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2018-08-22
- Decision date
- 2018-11-21
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the Medtronic CareLink Model 9986 Programmer Baseline Operating System Software.
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