Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
FDA premarket approval P210039/S001 · decided 2023-08-16
Approval details
- PMA number
- P210039
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Trireme Medical, LLC
- Date received
- 2023-05-04
- Decision date
- 2023-08-16
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasonton, CA
- Statement
- Approval for updated labeling, including the 24-month clinical study results, removed paclitaxel warning, and other minor modifications.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Chocolate XD PTCA Balloon Catheter (K153682) | Trireme Medical, LLC | 2016-06-23 |
| Chocolate PTCA Balloon Catheter (K150292) | Trireme Medical, LLC | 2015-04-09 |