MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218
FDA premarket approval P900061/S052 · decided 2002-06-12
Approval details
- PMA number
- P900061
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-05-30
- Decision date
- 2002-06-12
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9896 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 2090 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE JEWEL MODEL 7218.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.