MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP— 510(k) K041317
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K041317 for MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP, Substantially Equivalent on 2004-07-19. Applicant: Medtronic Minimed.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code LZG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northridge, CA, US
Adverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.