INSYNC ICD 7272
FDA premarket approval P010031/S004 · decided 2003-02-21
Approval details
- PMA number
- P010031
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC ICD 7272
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-12-03
- Decision date
- 2003-02-21
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
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