PHILOS DR-T PULSE GENERATOR
FDA premarket approval P950037/S023 · decided 2002-04-02
Approval details
- PMA number
- P950037
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHILOS DR-T PULSE GENERATOR
- Generic name
- permanent pacemaker Electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2002-02-11
- Decision date
- 2002-04-02
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR CHANGES TO THE PULSE GENERATOR TO ALLOW TRANSMISSION OF DIAGNOSTIC INFORMATION, AND FOR CHANGES TO THE PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR-T PULSE GENERATOR AND B-K00.T.U PROGRAMMER SOFTWARE, AND HAS THE SAME INDICATIONS AS THE CURRENTLY MARKETED PHILOS DR. SPECIFICALLY: 1) RATE ADAPTIVE PACING WITH PHILOS DR-T PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED
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510(k) clearances by this applicant
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