ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)
FDA premarket approval P990069 · decided 2002-11-27
Approval details
- PMA number
- P990069
- Trade name
- ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Applicant
- Dot Medical Products , Ltd.
- Date received
- 1999-11-01
- Decision date
- 2002-11-27
- Days to decision
- 1122 days
- Decision code
- APWD
- Product code
- MTE
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Macclesfield, Cheshire
- Statement
- APPROVAL FOR THE ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08). THE ALERT SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.
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