MEDTRONIC MODEL 9996 AND MODEL 9997
FDA premarket approval P980016/S055 · decided 2005-11-15
Approval details
- PMA number
- P980016
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 9996 AND MODEL 9997
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-09-13
- Decision date
- 2005-11-15
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MEDTRONIC MODEL 9996 AND MODEL 9997 APPLICATION SOFTWARE VERSION 2.0 USED WITH INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 ICD SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.