Product code DTA
- Device name
- Tester, Pacemaker Electrode Function
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3720
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P980023S012 | KENTROX RV-S/KENTROX SL-S ICD LEADS | Biotronik, Inc. | 2003-11-18 |
| P980023S013 | KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 | Biotronik, Inc. | 2003-07-29 |
| P980023S011 | IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S) | Biotronik, Inc. | 2002-12-20 |
| P980023S009 | KAINOX RV-S/ KAINOX VCS ICD LEADS | Biotronik, Inc. | 2002-11-25 |
| P980023S010 | ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) | Biotronik, Inc. | 2002-08-30 |
| P980023S008 | BELOS VR-T ICD | Biotronik, Inc. | 2002-04-24 |
| P980023S006 | BELOS VR ICD SYSTEM | Biotronik, Inc. | 2002-03-11 |
| P980023S007 | KENTROX RV LEAD SYSTEMS | Biotronik, Inc. | 2002-02-21 |
| P980023S005 | TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS | Biotronik, Inc. | 2001-10-24 |
| P980023S004 | BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | Biotronik, Inc. | 2001-07-12 |
| P980023S003 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | Biotronik, Inc. | 2000-05-01 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | 2017-02-28 |
| K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | St Jude Medical, Crmd | 2010-12-21 |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Biotronik, Inc. | 2007-12-20 |
| K050884 | ADAPTER CABLE | Remington Medical, Inc. | 2005-05-19 |
| K033613 | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | 2003-12-08 |
| K022360 | ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. | Biotronik, Inc. | 2003-01-27 |
| K933069 | MODEL EP-2 CLINICAL STIMULATOR | Ep Medical, Inc. | 1993-10-21 |
| K812104 | SIEMENS-ELEMA PSA 376 | Siemens Corp. | 1981-12-02 |
| K791380 | VA 1000 | Vitatron Medical BV | 1979-09-19 |
| K790503 | CARDIOTEST 2200 | Cardiac Pacemakers, Inc. | 1979-05-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000688400 | CareLink SmartSync™ | MEDTRONIC, INC. | 2022-10-28 |
| 04260451441173 | Osypka Medical | Osypka Medical GmbH | 2021-04-30 |
| 00763000201289 | CareLink SmartSync™ | MEDTRONIC, INC. | 2019-06-01 |
| 00763000002039 | CareLink SmartSync™ Azure Astra Application | MEDTRONIC, INC. | 2019-04-06 |
| 00643169957657 | CareLink SmartSync™ | MEDTRONIC, INC. | 2019-03-30 |
| 00643169833715 | CareLink SmartSync™ Common Application | MEDTRONIC, INC. | 2017-05-25 |
| 00643169833739 | CareLink SmartSync™ Common Application | MEDTRONIC, INC. | 2017-05-25 |
| 00643169868540 | CareLink SmartSync™ | MEDTRONIC, INC. | 2017-05-25 |