CONCERTO CRT-D
FDA premarket approval P010031/S072 · decided 2007-08-10
Approval details
- PMA number
- P010031
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-07-12
- Decision date
- 2007-08-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES INCLUDING: 1) MOVING THE ACCELEROMETER TESTING OPERATION EARLIER IN THE MANUFACTURING FLOW; 2) MOVING THE PATIENT ALERT RESTING OPERATION EARLIER IN THE MANUFACTURING PROCESS; AND 3) PERFORMING THE MEDICAL ADHESIVE CURING AND DEVICE PRE-HEAT PROCESS IN A SINGLE OVEN.
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