MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S— 510(k) K031917
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K031917 for MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S, Substantially Equivalent on 2003-08-19. Applicant: Medtronic Minimed. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code FPA
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- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Medtronic Minimed
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.