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 | Guardian Connect System |
| Applicant | MEDTRONIC MINIMED18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP160007 Supplement NumberS046 Date Received11/04/2022 Decision Date12/08/2022 Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-04 |
| Decision Date | 2022-12-08 |
| PMA | P160007 |
| Supplement | S046 |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED 18000 Devonshire Street northridge, CA 91325-1219 PMA NumberP160007 Supplement NumberS046 Date Received11/04/2022 Decision Date12/08/2022 Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of A New Supplier For The Thermoformed Packaging Tray For The Enlite Sensor And The Guardian Sensor (3). The Enlite Sensor Is A Components Of The MiniMed 530G, 630G, Paradigm Real-Time Revel, And IPro2 CGM Systems. The Guardian Sensor (3) Is A Component Of The MiniMed 630G, Guardian Connect, 670G And 770G Systems |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160007 | Original Filing | |
| S046 | 2022-11-04 | 30-day Notice |
| S045 | ||
| S044 | 2022-04-01 | 30-day Notice |
| S043 | ||
| S042 | 2021-11-17 | Special (immediate Track) |
| S041 | 2021-09-20 | 30-day Notice |
| S040 | 2021-01-27 | Special (immediate Track) |
| S039 | 2020-11-03 | 30-day Notice |
| S038 | ||
| S037 | 2020-08-04 | 30-day Notice |
| S036 | 2020-05-26 | 30-day Notice |
| S035 | ||
| S034 | 2020-01-08 | 30-day Notice |
| S033 | 2019-11-29 | 30-day Notice |
| S032 | ||
| S031 | 2019-11-27 | 30-day Notice |
| S030 | 2019-11-27 | 30-day Notice |
| S029 | ||
| S028 | 2019-10-17 | 30-day Notice |
| S027 | 2019-10-11 | 30-day Notice |
| S026 | ||
| S025 | 2019-08-21 | 30-day Notice |
| S024 | 2019-07-15 | 30-day Notice |
| S023 | 2019-06-19 | 30-day Notice |
| S022 | 2019-05-21 | 30-day Notice |
| S021 | 2019-05-17 | 30-day Notice |
| S020 | ||
| S019 | ||
| S018 | ||
| S017 | 2019-04-03 | 30-day Notice |
| S016 | 2019-02-25 | 30-day Notice |
| S015 | 2019-02-11 | 30-day Notice |
| S014 | ||
| S013 | 2019-02-01 | 30-day Notice |
| S012 | ||
| S011 | 2018-11-02 | 30-day Notice |
| S010 | 2018-10-15 | 30-day Notice |
| S009 | 2018-07-09 | 30-day Notice |
| S008 | 2018-07-02 | 30-day Notice |
| S007 | 2018-06-19 | 30-day Notice |
| S006 | 2018-06-07 | Special (immediate Track) |
| S005 | 2018-05-31 | 30-day Notice |
| S004 | 2018-05-18 | Real-time Process |
| S003 | 2018-05-11 | 30-day Notice |
| S002 | 2018-03-29 | 30-day Notice |
| S001 | 2018-03-26 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00763000186333 | P160007 | 000 |
| 00763000408893 | P160007 | 000 |
| 00763000408886 | P160007 | 000 |
| 00763000348021 | P160007 | 000 |
| 00763000455651 | P160007 | 000 |
| 00763000455682 | P160007 | 000 |
| 00763000455668 | P160007 | 000 |
| 00763000455675 | P160007 | 000 |
| 00763000516239 | P160007 | 000 |
| 00763000388355 | P160007 | 000 |
| 00763000179601 | P160007 | 000 |
| 00763000158392 | P160007 | 000 |
| 00763000399009 | P160007 | 000 |
| 00763000398330 | P160007 | 000 |
| 00763000002602 | P160007 | 000 |
| 00763000285852 | P160007 | 000 |
| 00763000002596 | P160007 | 000 |
| 20763000179629 | P160007 | 000 |
| 00763000388379 | P160007 | 003 |
| 00763000381097 | P160007 | 029 |
| 00763000381103 | P160007 | 029 |
| 00763000337001 | P160007 | 036 |
| 00763000337049 | P160007 | 036 |
| 00763000388379 | P160007 | 037 |
| 00763000388355 | P160007 | 037 |