BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
FDA premarket approval P010031/S351 · decided 2013-02-28
Approval details
- PMA number
- P010031
- Supplement
- S351
- 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
- 2013-02-05
- Decision date
- 2013-02-28
- Days to decision
- 23 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE TO THE AUTOMATED TEST EQUIPMENT SOFTWARE THAT TESTS AN IC TO IMPROVE MANUFACTURING YIELDS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.