PMA supplement
P890043 S032: ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM
FDA PMA supplement · Real-Time Process · Abbott Vascular
Key facts
| Original PMA | P890043 |
|---|---|
| Supplement number | S032 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Abbott Vascular |
| Product code | MCX |
| Received date | Jul 9, 1997 |
| Decision date | Jun 8, 1998 |
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: