INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D
FDA premarket approval P010031/S134 · decided 2008-12-17
Approval details
- PMA number
- P010031
- Supplement
- S134
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-11-20
- Decision date
- 2008-12-17
- Days to decision
- 27 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
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