CONSULTA II CRT-D, CONSULTA, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA, PROTECTA XT
FDA premarket approval P010031/S298 · decided 2012-04-23
Approval details
- PMA number
- P010031
- Supplement
- S298
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA II CRT-D, CONSULTA, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA, PROTECTA XT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-03-28
- Decision date
- 2012-04-23
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE TO THE HYBRID BURN-IN TIME.
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