BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE
FDA premarket approval P950037/S020 · decided 2001-10-10
Approval details
- PMA number
- P950037
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE
- Generic name
- permanent pacemaker Electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2001-06-11
- Decision date
- 2001-10-10
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR PULSE GENERATOR AND PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INOS2+ AND IS INDICATED FOR THE FOLLOWING APPLICATIONS: 1) RATE ADAPTIVE PACING WITH THE INOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. 2) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADY
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510(k) clearances by this applicant
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