PMA supplement
P970029 S025: PEARL 8.0 HANDPIECE
FDA PMA supplement · Normal 180 Day Track No User Fee · Cryolife, Inc.
Key facts
| Original PMA | P970029 |
|---|---|
| Supplement number | S025 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | PEARL 8.0 HANDPIECE |
| Generic name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Applicant | Cryolife, Inc. |
| Product code | MNO |
| Received date | Nov 26, 2013 |
| Decision date | Jan 28, 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: