MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT
FDA premarket approval P980016/S132 · decided 2008-10-01
Approval details
- PMA number
- P980016
- Supplement
- S132
- 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
- Implantable cardioverter defibrillator (non-CRT)
- 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
- LWS
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.