PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D
FDA premarket approval P010031/S314 · decided 2012-09-10
Approval details
- PMA number
- P010031
- Supplement
- S314
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-06-11
- Decision date
- 2012-09-10
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- PROTECTA CRT-D MODEL D334TRG; PROTECTA DF4 CRT-D MODEL 334TRM: PROTECTA XTCRT-D MODEL D314TRG; AND PROTECTA XT DF4 CRT-D MODEL D314TRM.
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