IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
FDA premarket approval P190008/S021 · decided 2022-11-01
Approval details
- PMA number
- P190008
- Supplement
- S021
- 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
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2022-10-31
- Decision date
- 2022-11-01
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |