GENESA(R) SYSTEM
FDA premarket approval P940001 · decided 1997-09-12
Approval details
- PMA number
- P940001
- Trade name
- GENESA(R) SYSTEM
- Generic name
- Pump, drug administration, closed loop
- Applicant
- Gensia, Inc.
- Date received
- 1994-01-03
- Decision date
- 1997-09-12
- Days to decision
- 1348 days
- Decision code
- APWD
- Product code
- MQT
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- This device indicated for delivering arbutamine, a catecholamine, through a closed-loop, computer-controlled drug-delivery system to elicit acute cardiovascular responses similar to those produced by exercise. In pts w/suspected coronary artery disease (CAD) who cannot exercise adequately, stress induction with the GenESA(R) System is indicated as an aid in diagnosing the presence or absence of CAD. The effectiveness of the device has been demonstrate in clinical studies using radionuclide myoca
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