MEDTRONIC CARELINK 2290
FDA premarket approval P890003/S263 · decided 2012-12-11
Approval details
- PMA number
- P890003
- Supplement
- S263
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CARELINK 2290
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2012-10-11
- Decision date
- 2012-12-11
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF AN UPDATE TO THE 2290 ANALYZER SOFTWARE.
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