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 the addition of a 100% in-line inspection for gel lumps in the body tubing of the myopore lead.
| Device | Myopore Sutureless Myocardial Pacing Lead |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Greatbatch Medical |
| Date Received | 2017-05-12 |
| Decision Date | 2017-06-08 |
| PMA | P130012 |
| Supplement | S003 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |