D286 CURRENT DRAIN LIMITS
FDA premarket approval P010031/S348 · decided 2013-02-28
Approval details
- PMA number
- P010031
- Supplement
- S348
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- D286 CURRENT DRAIN LIMITS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-04
- Decision date
- 2013-02-28
- Days to decision
- 24 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE TO THE CURRENT DRAIN RELATED LIMITS FOR AN IC TO PREVENT EXCESSIVE YIELD FALLOUT.
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