This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the myopore sutureless myocardial pacing lead. This device is indicated for when ventricular epicardial attachment is required, or when a transvenous lead cannot provide effective pacing. This type of lead is useful in situations where it is required that the potential for lead dislodgement be diminished or pacing and/or sensing will be established subsequent to open heart surgery.
| Device | MYOPORE SUTURELESS MYOCARDIAL PACING LEAD |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Greatbatch Medical |
| Date Received | 2013-05-13 |
| Decision Date | 2015-04-30 |
| Notice Date | 2015-05-08 |
| PMA | P130012 |
| Supplement | S |
| Product Code | DTB |
| Docket Number | 15M-1557 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Greatbatch Medical 2300 Berkshire Lane North minneapolis, MN 55441 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |