FDA Registration
Active
🇮🇪 Ireland
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Reg #: 9612164
·
FEI: 3002806434
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTRONIC IRELAND
- Registration Number
- 9612164
- FEI Number
- 3002806434
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PARKMORE BUSINESS PARK WEST
- City
- GALWAY
- Country
- IE
Regulatory Submissions
- PMA Number
- P190008
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- Medtronic Vascular
- Contact Name
- GERARDINE FINN
- Address
- 3576 Unocal Place
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
- [email protected]
- Phone
- 707 5661548
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug-Coated Peripheral Transluminal Angioplasty Catheter | PRC | Class 3 | Unknown | No | 2019-11-21 |
Proprietary Names
IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Establishment Types
Manufacture Medical Device