BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
FDA premarket approval P010031/S428 · decided 2014-03-05
Approval details
- PMA number
- P010031
- Supplement
- S428
- 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
- 2014-02-18
- Decision date
- 2014-03-05
- Days to decision
- 15 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE CRIMPING PROCESS FOR THE FEED THROUGH ASSEMBLY USED IN THE MANUFACTURE OF SELECTED IMPLANTABLE CARDIAC DEFIBRILLATORS (ICD) AND CARDIOVERTER RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D).
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