ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT
FDA premarket approval P900061/S070 · decided 2006-12-11
Approval details
- PMA number
- P900061
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Trade name
- ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-11-20
- Decision date
- 2006-12-11
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
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