| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | MINIMED 530G INSULIN PUMP |
|---|
| Generic Name | Automated insulin dosing , threshold suspend |
|---|
| Applicant | Medtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325 |
|---|
| PMA Number | P120010 |
|---|
| Supplement Number | S005 |
|---|
| Date Received | 11/08/2013 |
|---|
| Decision Date | 08/21/2014 |
|---|
| Product Code |
OZO |
| Advisory Committee |
Clinical Chemistry |
|---|
| Clinical Trials | NCT01112696
|
|---|
| Supplement Type | 135 Review Track For 30-Day Notice |
|---|
| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order Statement
APPROVAL FOR THE IMPLEMENTATION OF A PNEUMATIC PRESS TOOL IN PLACEOF A MANUAL PRESS TOOL IN THE MANUFACTURING PROCESS OF THE PARADIGM REAL-TIME INSULIN PUMP(MODELS:MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVELINSULIN-PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), GUARDIAN REALTIMEMONITOR (MODELS: CSS7100 AND CSS17100K) AND THE MINIMED 530G INSULIN PUMP(MODELS: MMT-551 AND MMT-751). THESE PARTS ARE COMPONENTS OF THE PARADIGM REAL-TIMESYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CONTINUOUS GLUCOSEMONITORING SYSTEMS AND THE MINIMED 530G SYSTEM RESPECTIVELY. |
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
|
|
