LUMAX CRT DEVICE & CARDIOMESSENGER II
FDA premarket approval P050023/S003 · decided 2007-02-13
Approval details
- PMA number
- P050023
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUMAX CRT DEVICE & CARDIOMESSENGER II
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2007-01-22
- Decision date
- 2007-02-13
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR MODIFICATIONS TO THE CARDIOMESSENGER AND CARDIOMESSENGER II USED WITH THE REFERENCED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: CARDIOMESSENGER TLINE AND CARDIOMESSENGER II LLT AND ARE INDICATED FOR TRANSMITTING DIAGNOSTIC PATIENT DATA FROM THE DEVICE TO THE PHYSICIAN.
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510(k) clearances by this applicant
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