INSYNC FAMILIES OF ICD & CONCERTO ICD
FDA premarket approval P010031/S087 · decided 2007-12-11
Approval details
- PMA number
- P010031
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC FAMILIES OF ICD & CONCERTO ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-11-19
- Decision date
- 2007-12-11
- Days to decision
- 22 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
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