PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE
FDA premarket approval P950037/S037 · decided 2004-03-31
Approval details
- PMA number
- P950037
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Biotronik, Inc.
- Date received
- 2004-02-12
- Decision date
- 2004-03-31
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE ADDITION OF TWO CARDIO REPORT TRIGGERS FOR THE PHILOS DR-T PULSE GENERATOR AND FOR REVISIONS TO THE A-K00.1.U/5 PROGRAMMER SOFTWARE WHICH ARE NECESSARY IN ORDER TO UTILIZE THE MODIFIED PHILOS DR-T.
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510(k) clearances by this applicant
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