PMA supplement
P980016 S002: MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP
FDA PMA supplement · Normal 180 Day Track · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Received date | Dec 7, 1998 |
| Decision date | Jan 28, 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: