ASPIRESR GENERATOR -MODEL 106
FDA premarket approval P970003/S182 · decided 2015-12-18
Approval details
- PMA number
- P970003
- Supplement
- S182
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ASPIRESR GENERATOR -MODEL 106
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2015-07-01
- Decision date
- 2015-12-18
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR USING A 2-POSITION PRE-SURGICAL SURFACE ELECTROCARDIOGRAPH (ECG) ASSESSMENT PROCEDURE TO IDENTIFY IMPLANT LOCATION.
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