BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)
FDA premarket approval P010031/S354 · decided 2013-03-07
Approval details
- PMA number
- P010031
- Supplement
- S354
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-06
- Decision date
- 2013-03-07
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT CRT-D SYSTEMS, CORRECTIONS TO THE SUBJECT SYSTEMS¿ BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES, AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS.
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