PMA P950037S084
- Device
- REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S084
- Product code
- OVJ
- Decision date
- 2012-05-08
- Classification
- Pulse Generator, External Pacemaker, Dual Chamber
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Approval order statement
- APPROVAL FOR TWO NEW FAMILIES OF TEMPORARY EXTERNAL PACEMAKER PULSE GENERATORS. NEW FEATURES INCLUDE: 1) REDEL PACING WIRE CONNECTION ADAPTERS; 2) TRIGGER MODES VT AND SST; 3) SENSITIVITY SETTINGS UP TO 20 MV FOR THE REOCOR S MODEL; AND 3) PROGRAMMABLE AV DELAY UP TO 400 MS. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES REOCOR S AND REOCOR D AND IS INDICATED FOR: TEMPORARY PACING; TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; SYMPTOMATIC SINUS BRADYCARDIA; PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; TERMINATION OF SUPRAVENTRICULAR TACHYARRHYTHMIAS; PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS; EMERGENCY PACING; AND CHECKING PACING THRESHOLDS.
Current openFDA PMA Record#
- Device
- REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S084
- Product code
- OVJ
- Generic name
- Pulse Generator, External Pacemaker, Dual Chamber
- Decision date
- 2012-05-08
- Decision code
- APPR
- Date received
- 2010-07-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO NEW FAMILIES OF TEMPORARY EXTERNAL PACEMAKER PULSE GENERATORS. NEW FEATURES INCLUDE: 1) REDEL PACING WIRE CONNECTION ADAPTERS; 2) TRIGGER MODES VT AND SST; 3) SENSITIVITY SETTINGS UP TO 20 MV FOR THE REOCOR S MODEL; AND 3) PROGRAMMABLE AV DELAY UP TO 400 MS. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES REOCOR S AND REOCOR D AND IS INDICATED FOR: TEMPORARY PACING; TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; SYMPTOMATIC SINUS BRADYCARDIA; PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; TERMINATION OF SUPRAVENTRICULAR TACHYARRHYTHMIAS; PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS; EMERGENCY PACING; AND CHECKING PACING THRESHOLDS.