K981083
Substantially Equivalent - Subject to Tracking Reg.RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
- Applicant
- Biotronik, Inc.
- Product code
- DTB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, 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.