IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
FDA premarket approval P190008 · decided 2019-11-21
Approval details
- PMA number
- P190008
- Trade name
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2019-04-03
- Decision date
- 2019-11-21
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the IN.PACT AV Paclitaxel-coated PTA Balloon Catheter. The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |