FDA Registration
Active
🇺🇸 United States
Suture Sleeve Accessory DS2A088
Reg #: 3006705815
·
FEI: 3006705815
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3006705815
- FEI Number
- 3006705815
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- LOT A INTERIOR - No. 2 RD KM 67.5, SANTANA INDUSTRIAL PARK
- City
- Arecibo
- State
- PR
- ZIP
- 00612
- Country
- US
Regulatory Submissions
- PMA Number
- P960013
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2007-11-09 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2007-11-09 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2007-11-09 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2007-11-09 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2007-11-09 |
Proprietary Names
Suture Sleeve Accessory DS2A088
UltiPace Bradycardia Pacing Lead Model LPA1231
Tendril SDX, Tendril ST, Tendril STS, OptiSense, Tendril DX Leads
Establishment Types
Manufacture Medical Device