K013339
Substantially Equivalent - Subject to Tracking Reg.PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
- Applicant
- Oscor, Inc.
- Product code
- DTB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Special
- Location
- Palm Harbor, FL, US
Adverse events under product code DTB
product code DTB- Death
- 1,491
- Injury
- 67,311
- Malfunction
- 79,368
- Other
- 10
- Total
- 148,180
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.