BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA premarket approval P010031/S357 · decided 2013-03-07
Approval details
- PMA number
- P010031
- Supplement
- S357
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-07
- Decision date
- 2013-03-07
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MULTIPLE MANUFACTURING CHANGES PREVIOUSLY ACCEPTED FOR OTHER MARKET RELEASED MEDTRONIC DEVICES, WHICH INCLUDED: 1) CMOS PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATES TO THE TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS; 3) ADDITION OF HIGH TEMPERATURE MONITORING TO THE HIGH POWER LEAN LINE; 4) UPDATE TO A MANUFACTURING ASSEMBLY CONTROLLER SYSTEM; 5) IMPLEMENTATION OF A NEW CLEANING PROCESS AND CURING OVEN; AND 6) AND IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VA
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