PMA supplement
P950015 S012: HEART LASER CO2 TMR SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Laser Engineering Heart, Inc.
Key facts
| Original PMA | P950015 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HEART LASER CO2 TMR SYSTEM |
| Generic name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Applicant | Laser Engineering Heart, Inc. |
| Product code | MNO |
| Received date | Oct 7, 2013 |
| Decision date | Jul 23, 2014 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: