Indevus Pharmaceuticals, Inc.: FDA clearances and approvals
Indevus Pharmaceuticals, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMW | Solution, Removal, Carries | 1 | 0 |
Review panels
- Dental (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830035 | PMA | GK-101E CARIES REMOVAL AGENT/SYSTEM | 1984-07-06 |
Recalls
openFDA lists no recalls under a recalling firm named Indevus Pharmaceuticals, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Indevus Pharmaceuticals, Inc. have?
Indevus Pharmaceuticals, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Indevus Pharmaceuticals, Inc. make?
Its most frequent FDA product codes are LMW (Solution, Removal, Carries, 1).
Has Indevus Pharmaceuticals, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Indevus Pharmaceuticals, Inc. Related entities may recall under other names.
Next steps
- See all 0 Indevus Pharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMW, Indevus Pharmaceuticals, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.