Surmodics SurVeil Drug-Coated Balloon
FDA premarket approval P210025/S001 · decided 2024-01-03
Approval details
- PMA number
- P210025
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surmodics SurVeil Drug-Coated Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Surmodics,Inc.
- Date received
- 2023-12-06
- Decision date
- 2024-01-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- addition of a dose audit site.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Pounce(TM) Sheath (K252227) | Surmodics,Inc. | 2025-09-24 |
| Pounce XL Thrombectomy System (PTS-1011-7F135) (K241362) | Surmodics,Inc. | 2024-09-11 |
| Microcatheter (K232647) | Surmodics,Inc. | 2023-09-29 |
| Pounce™ Sheath (K231828) | Surmodics,Inc. | 2023-09-07 |
| Pounce™ Thrombectomy System (K231022) | Surmodics,Inc. | 2023-06-12 |
| Sublime Microcatheter (K221886) | Surmodics,Inc. | 2022-10-14 |
| Pounce Thrombectomy System (K220501) | Surmodics,Inc. | 2022-03-23 |
| Pounce Thrombectomy System (K211492) | Surmodics,Inc. | 2021-07-30 |