FDA Registration
Active
🇺🇸 United States
Organ Care System (OCS) Heart
Reg #: 3003152463
·
FEI: 3003152463
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TRANSMEDICS, INC.
- Registration Number
- 3003152463
- FEI Number
- 3003152463
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200 MINUTEMAN RD STE 302
- City
- Andover
- State
- MA
- ZIP
- 01810
- Country
- US
Regulatory Submissions
- PMA Number
- P180051
Owner / Operator
- Firm Name
- TransMedics
- Operator Number
- 10045349
- Address
- 200 Minuteman Road, Suite 302
- City
- Andover
- State
- MA
- Postal Code
- 01810
- Country
- US
- Correspondent
- Miriam Provost
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Organ Care System (Ocs) Heart System | QIK | Class 3 | Unknown | No | 2021-09-22 |
Proprietary Names
Organ Care System (OCS) Heart
Establishment Types
Manufacture Medical Device