INSYNCC III MARQUIS ICD, INSYNC MAXIMO ICD
FDA premarket approval P010031/S448 · decided 2014-07-11
Approval details
- PMA number
- P010031
- Supplement
- S448
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNCC III MARQUIS ICD, INSYNC MAXIMO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-06-13
- Decision date
- 2014-07-11
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SUPPLIER CHANGE AND SPECIFICATION UPDATE TO P(ETFE) USED IN MEDTRONIC CRDM LITHIUM-ORGANIC ELECTROLYTE BATTERIES.
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