INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS
FDA premarket approval P010031/S180 · decided 2010-02-18
Approval details
- PMA number
- P010031
- Supplement
- S180
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-01-13
- Decision date
- 2010-02-18
- Days to decision
- 36 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
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