PMA supplement
P860007 S021: IMPLANTABLE PACEMAKER LEADS
FDA PMA supplement · Normal 180 Day Track · Boston Scientific
Key facts
| Original PMA | P860007 |
|---|---|
| Supplement number | S021 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Express GMP Supplement |
| Trade name | IMPLANTABLE PACEMAKER LEADS |
| Generic name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
| Applicant | Boston Scientific |
| Product code | LWW |
| Received date | Oct 25, 1999 |
| Decision date | Dec 2, 1999 |
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: