SELECTED FAMILIES OF ICDS
FDA premarket approval P980016/S083 · decided 2006-09-19
Approval details
- PMA number
- P980016
- Supplement
- S083
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- SELECTED FAMILIES OF ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-08-21
- Decision date
- 2006-09-19
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA FOR THE FINAL TESTING, ACTIVATING, LABELING AND PACKAGING OF THE MODEL 2490H CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER.
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