INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICD
FDA premarket approval P010031/S136 · decided 2008-12-24
Approval details
- PMA number
- P010031
- Supplement
- S136
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-11-26
- Decision date
- 2008-12-24
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN MANUFACTURING LOCATION OF THE CHIP RESISTORS.
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