IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter
FDA premarket approval P190008/S027 · decided 2023-10-12
Approval details
- PMA number
- P190008
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2023-09-28
- Decision date
- 2023-10-12
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- removal of operators hands/gloves testing from the environmental monitoring program for all devices, manufactured at Medtronic Ireland in controlled environment areas meeting ISO Class 8 requirements
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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 |