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.
Approval for revisions and enhancements to the content in the myopore lead instructions for use.
| Device | Myopore Sutureless Myocardial Pacing Lead |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Greatbatch Medical |
| Date Received | 2019-01-30 |
| Decision Date | 2019-02-21 |
| PMA | P130012 |
| Supplement | S006 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Greatbatch Medical 2300 Berkshire Lane North minneapolis, MN 55441 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130012 | Original Filing | |
| S010 | 2022-08-08 | 135 Review Track For 30-day Notice |
| S009 | 2022-08-05 | 30-day Notice |
| S008 | 2019-06-19 | 30-day Notice |
| S007 | ||
| S006 | 2019-01-30 | Special (immediate Track) |
| S005 | 2018-08-27 | 30-day Notice |
| S004 | ||
| S003 | 2017-05-12 | Special (immediate Track) |
| S002 | 2016-08-29 | 30-day Notice |
| S001 | 2016-08-23 | 30-day Notice |