PMA supplement
P980023 S015: CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168
FDA PMA supplement · Normal 180 Day Track No User Fee · Biotronik, Inc.
Key facts
| Original PMA | P980023 |
|---|---|
| Supplement number | S015 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168 |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Biotronik, Inc. |
| Product code | LWS |
| Received date | Jul 16, 2003 |
| Decision date | Oct 31, 2003 |
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: