FDA 510(k) Applications for Medical Device:
Permanent Pacemaker Electrode
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K000763 | BIOTRONIK, GMBH & CO. |
6024 JEAN RD. | LAKE OSWEGO | OR | 97035 |
| K023099 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K021217 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K061212 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K964604 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K965106 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K001413 | BIOTRONIK, INC. |
6024 SW JEAN RD. B4 | LAKE OSWEGO | OR | 97035-3594 |
| K023205 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K994240 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K010281 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K023803 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K003072 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K990483 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K981083 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K991169 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K980869 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K972500 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K953044 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K993139 | BIOTRONIK, INC. |
6024 JEAN ROAD | LAKE OSWEGO | OR | 97035 |
| K963738 | ELA MEDICAL, INC. |
15245 MINNETONKA BLVD. | MINNETONKA | MN | 55345 |
| K972574 | ELA MEDICAL, INC. |
2950 XENIUM LN. NORTH | PLYMOUTH | MN | 55441 |
| K000029 | ELA MEDICAL, INC. |
2950 XENIUM LN. NORTH | PLYMOUTH | MN | 55441 |
| K993448 | ELA MEDICAL, INC. |
2950 XENIUM LN. NORTH, #120 | PLYMOUTH | MN | 55441 |
| K962174 | INTERMEDICS, INC. |
4000 TECHNOLOGY DR. | ANGLETON | TX | 77515 |
| K955550 | INTERMEDICS, INC. |
4000 TECHNOLOGY DR. | ANGLETON | TX | 77515 |
| K960281 | INTERMEDICS, INC. |
4000 TECHNOLOGY DR. | ANGLETON | TX | 77515 |
| K954719 | INTERMEDICS, INC. |
4000 TECHNOLOGY DR. | ANGLETON | TX | 77515 |
| K955122 | INTERMEDICS, INC. |
4000 TECHNOLOGY DR. | ANGLETON | TX | 77515 |
| K954610 | INTERMEDICS, INC. |
4000 TECHNOLOGY DR. | ANGLETON | TX | 77515 |
| K962036 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE, N.E. | MINNEAPOLIS | MN | 55432-3576 |
| K961936 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE, N.E. | MINNEAPOLIS | MN | 55432-3576 |
| K031274 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE | MINNEAPOLIS | MN | 55432-3576 |
| K961679 | MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE, N.E. | MINNEAPOLIS | MN | 55432-3576 |
| K031210 | METRONIC, INC. |
7000 CENTRAL AVE. N.E. | MINNEAPOLIS | MN | 55432 |
| K003918 | Oscor Inc. |
3816 DeSoto Blvd. | Palm Harbor | FL | 34683 |
| K013339 | Oscor Inc. |
3816 DE SOTO BLVD. | PALM HARBOR | FL | 34683 |
| K041809 | Oscor Inc. |
3816 DE SOTO BLVD. | PALM HARBOR | FL | 34683 |
| K040569 | Oscor Inc. |
3816 DE SOTO BLVD. | PALM HARBOR | FL | 34683 |
| K020669 | Oscor Inc. |
3816 DE SOTO BLVD. | PALM HARBOR | FL | 34683 |
| K024053 | Oscor Inc. |
3816 DE SOTO BLVD. | PALM HARBOR | FL | 34683 |
| K964107 | OSCOR MEDICAL CORP. |
3816 DESOTO BLVD. | PALM HARBOR | FL | 34683 |
| K954714 | PACESETTER, INC. |
15900 VALLEY VIEW COURT | SYLMAR | CA | 91342-3577 |
| K972814 | PACESETTER, INC. |
15900 VALLEY VIEW COURT | SYLMAR | CA | 91342-3577 |
| K990142 | SULZER OSCOR, INC. |
3816 DeSoto Blvd. | Palm Harbor | FL | 34683 |
| K961118 | TELECTRONICS PACING SYSTEMS, INC. |
7400 SOUTH TUCSON WAY | ENGLEWOOD | CO | 80112 |
| K943657 | TELECTRONICS PACING SYSTEMS, INC. |
7400 SOUTH TUCSON WAY | ENGLEWOOD | CO | 80112 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
