Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
FDA premarket approval P210039 · decided 2022-11-04
Approval details
- PMA number
- P210039
- 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
- 2021-12-27
- Decision date
- 2022-11-04
- Days to decision
- 312 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasonton, CA
- Statement
- Approval of the Chocolate Touch® (Paclitaxel Coated PTA Balloon Catheter). The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4.0 mm to 6.0 mm.
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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 |