PMA supplement
P860008 S011: ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS
FDA PMA supplement · Normal 180 Day Track · Cardio Command
Key facts
| Original PMA | P860008 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS |
| Generic name | SYSTEM, ESOPHAGEAL PACING |
| Applicant | Cardio Command |
| Product code | LPA |
| Received date | Jun 20, 1991 |
| Decision date | Aug 6, 1992 |
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: