MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER
FDA premarket approval P900061/S046 · decided 2001-09-05
Approval details
- PMA number
- P900061
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-07-25
- Decision date
- 2001-09-05
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) AND MODEL 5460 ACE HEADER. THE DEVICE IS USED TO EMULATE AN IMPLANTABLE DEVICE DURING DEFIBRILLATION EFFICACY TESTING.
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