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/S044 · decided 2011-05-06
Approval details
- PMA number
- P050023
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2011-03-23
- Decision date
- 2011-05-06
- Days to decision
- 44 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- ADDITION OF AN INSPECTION STEP DURING THE BATTERY MANUFACTURING PROCESS.
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510(k) clearances by this applicant
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