Syncardia Systems, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Syncardia Systems, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOZ | Artificial Heart | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030011 | PMA | SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) | 2004-10-15 |
Recalls
5 product recalls in 5 recall events; 2 initiated in the last five years. Most recent: 2023-08-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Syncardia Systems, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00614510: SynCardia CardioWest TAH-t Postmarket Surveillance Study (Completed, started 2006-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syncardia Systems, LLC?
FDA lists 0 510(k) clearances under the applicant name “Syncardia Systems, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Syncardia Systems, LLC?
The most frequent FDA product codes under this applicant name are LOZ (Artificial Heart, 1).
Next steps
- See all 0 Syncardia Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code LOZ, Syncardia Systems, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.