FDA Registration
Active
🇺🇸 United States
Suture Sleeve Accessory DS2A088
Reg #: 3013288201
·
FEI: 3013288201
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ABBOTT MEDICAL
- Registration Number
- 3013288201
- FEI Number
- 3013288201
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14901 Deveau Pl. Building 2
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- 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
Complaint File Establishment per 21 CFR 820.198