Data / Medical devices / United States / Medtronic Puerto Rico Operations Co., Juncos
Medtronic Puerto Rico Operations Co., Juncos: FDA-registered device maker in Juncos, PR, United States, 7 510(k) clearances and 7 PMA approvals
Medtronic Puerto Rico Operations Co., Juncos is registered with the FDA (registration 3042027705) in Juncos, PR, United States. It lists 10 device types. The FDA files 7 510(k) clearances and 7 PMA approvals under its listings, the newest dated August 6, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042027705
- Address
- Road 31, KM. 24, HM 4, Ceiba Norte Industrial Park, Juncos, PR, United States, 00777
- Owner or operator
- Medtronic (10094334)
- Roles
- Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler
- First device listed
- July 26, 2005
- Registered through
- 2027
- Brand names listed
- CSS7100 GUARDIAN REAL-TIME MONITOR, CSS7100k GUARDIAN REAL-TIME MONITOR, CSS72 Guardian REAL-Time Continuous Glucose Monitoring System, CSS7200 Guardian Connect App, MEDTRONIC MINIMED INFUSION PUMP, MMT-103A MiniMed Reservoir, MMT-103AT MiniMed Reservoir, MMT-1510 MiniMed 620G Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Manufacturer | accessdata.fda.gov |
| Automated Insulin Dosing , Threshold Suspend | OZO | 3 | Manufacturer, Manufacturer for export, Remanufacturer | accessdata.fda.gov |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | 3 | Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Calculator, Drug Dose | NDC | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | OYC | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Sensor, Glucose, Invasive | MDS | 3 | Manufacturer | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System | SFI | 3 | Manufacturer | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2025 | K251032 | MiniMed 780G insulin pump | QFG | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| April 6, 2022 | K210714 | Extended Reservoir | LZG | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| May 21, 2004 | K040676 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 | LZG | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| August 22, 2003 | K032005 | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 | FRN | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| August 18, 2000 | K001829 | MINIMED PARADIGM INSULIN PUMP, MODEL 511 | FRN | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| August 18, 2000 | K001828 | PARADIGM 1.5ML RESERVOIR, MODEL 326 | FRN | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| January 18, 2000 | K991936 | 3.0 ML RESERVOIR, MODEL 103/193 | FRN | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 6, 2025 | P250012 | Simplera Sync Sensor, Guardian 4 Sensor | SFI | 11 | July 21, 2026 | accessdata.fda.gov |
| March 8, 2018 | P160007 | Guardian Connect system | MDS | 55 | July 21, 2026 | accessdata.fda.gov |
| September 28, 2016 | P160017 | MiniMed 670G System | OZP | 126 | September 29, 2026 | accessdata.fda.gov |
| August 10, 2016 | P150001 | MINIMED 630G SYSTEM WITH SMARTGUARD(TM) | OZO | 100 | July 21, 2026 | accessdata.fda.gov |
| December 7, 2015 | P150019 | PARADIGM REAL-TIME REVEL SYSTEM | MDS | 61 | April 29, 2022 | accessdata.fda.gov |
| September 26, 2013 | P120010 | MINIMED 530G SYSTEM | OZO | 135 | July 21, 2026 | accessdata.fda.gov |
| June 15, 1999 | P980022 | CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | 186 | August 14, 2019 | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion
- All makers of Automated Insulin Dosing Device System, Single Hormonal Control
- All makers of Automated Insulin Dosing , Threshold Suspend
- All makers of Pump, Infusion, Insulin
- All makers of Sensor, Glucose, Invasive
- All makers of Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Updated July 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.