FDA Registration
Active
🇲🇾 Malaysia
Symplicity Spyral Renal Denervation System
Reg #: 3004593495
·
FEI: 3004593495
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Plexus Manufacturing Sdn. Bhd.
- Registration Number
- 3004593495
- FEI Number
- 3004593495
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bayan Lepas Free Industrial Zone, Phase II
- City
- Bayan Lepas Pulau Pinang
- Country
- MY
Regulatory Submissions
- PMA Number
- P220026
Owner / Operator
- Firm Name
- PLEXUS CORP.
- Operator Number
- 3019588
- Address
- ONE PLEXUS WAY, --
- City
- Neenah
- State
- WI
- Postal Code
- 54956
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ablation Catheter, Renal Denervation | QYI | Class 3 | Unknown | No | 2023-11-19 |
Proprietary Names
Symplicity Spyral Renal Denervation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)