APPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO
FDA premarket approval P900061/S134 · decided 2015-06-04
Approval details
- PMA number
- P900061
- Supplement
- S134
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-04-14
- Decision date
- 2015-06-04
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.