CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, PROTECTA CRT-D, DF4 CRT-D, XT CRT-D, XT DR, XT DF4 CRT-D
FDA premarket approval P010031/S310 · decided 2013-03-26
Approval details
- PMA number
- P010031
- Supplement
- S310
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, PROTECTA CRT-D, DF4 CRT-D, XT CRT-D, XT DR, XT DF4 CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-21
- Decision date
- 2013-03-26
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.