MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT
FDA premarket approval P010031/S101 · decided 2008-10-01
Approval details
- PMA number
- P010031
- Supplement
- S101
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-06-02
- Decision date
- 2008-10-01
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PLEXUS-PENANG, PENANG, MALAYSIA, FOR THE TESTING, LABELING AND PACKAGING OF THE DEVICE.
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