BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRT
FDA premarket approval P010031/S423 · decided 2014-02-27
Approval details
- PMA number
- P010031
- Supplement
- S423
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-01-30
- Decision date
- 2014-02-27
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- NEW CURE AND PRE-HEAT OVEN FOR THE MEDICAL ADHESIVE CURING PROCESS FOR THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.