LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX
FDA premarket approval P050023/S045 · decided 2011-05-26
Approval details
- PMA number
- P050023
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2011-04-11
- Decision date
- 2011-05-26
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
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510(k) clearances by this applicant
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