K063091

Substantially Equivalent

PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601

Applicant: Tyrx Pharma, Inc.
Product code: FTL
Advisory panel: General, Plastic Surgery
Date received: 2006-10-10
Decision date: 2008-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Junction, NJ, US

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.