PMA supplement
P960006 S005: FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616
FDA PMA supplement · Normal 180 Day Track · Boston Scientific
Key facts
| Original PMA | P960006 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616 |
| Generic name | Permanent pacemaker Electrode |
| Applicant | Boston Scientific |
| Product code | DTB |
| Received date | Jul 11, 2001 |
| Decision date | Feb 4, 2002 |
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: