PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1
FDA premarket approval P950037/S030 · decided 2003-08-04
Approval details
- PMA number
- P950037
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Biotronik, Inc.
- Date received
- 2003-01-09
- Decision date
- 2003-08-04
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A MODIFIED PHILOS DR PACING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1 AND IS INDICATED FOR USE IN PATIENTS WITH STANDARD BRADYCARDIA PACING INDICATIONS. RATE-ADAPTIVE PACING WITH THE PHILOS DR ACC PULSE GENERATOR IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICA
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510(k) clearances by this applicant
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