PMA
P030037: RITHRON-XR CORONARY STENT SYSTEM
FDA PMA · STENT, CORONARY · Biotronik GmbH & Co. KG
Key facts
| PMA number | P030037 |
|---|---|
| Trade name | RITHRON-XR CORONARY STENT SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Biotronik GmbH & Co. KG |
| Owner/operator | BIOTRONIK AG |
| Product code | MAF |
| Approval date | Apr 29, 2005 |
| Docket number | 05M-0193 |
| Notice date | May 18, 2005 |
| Establishment registration | 8043892 |
| FEI number | 3002808050 |
At a glance
- None Supplements
- Apr 29, 2005 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: