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.
Modification of the manufacturing location of an existing component supplier.
| Device | Myopore Sutureless Myocardial Pacing Lead |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Greatbatch Medical |
| Date Received | 2018-08-27 |
| Decision Date | 2018-09-25 |
| PMA | P130012 |
| Supplement | S005 |
| Product Code | DTB |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| 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 |