PMA supplement
P820022 S002: CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER
FDA PMA supplement · Normal 180 Day Track · Boston Scientific
Key facts
| Original PMA | P820022 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER |
| Generic name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
| Applicant | Boston Scientific |
| Product code | LWW |
| Received date | Sep 18, 1989 |
| Decision date | Feb 16, 1990 |
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: