ALERT SYSTEM-COMPANION II
FDA premarket approval P990069/S001 · decided 2003-09-29
Approval details
- PMA number
- P990069
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALERT SYSTEM-COMPANION II
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Applicant
- Dot Medical Products , Ltd.
- Date received
- 2003-04-28
- Decision date
- 2003-09-29
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- MTE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Macclesfield, Cheshire
- Statement
- APPROVAL FOR THE ALERT SYSTEM, COMPANION II. THE DEVICE, AS MODIFIED, IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.
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