ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION
FDA premarket approval P880086/S095 · decided 2003-08-15
Approval details
- PMA number
- P880086
- Supplement
- S095
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2003-08-05
- Decision date
- 2003-08-15
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES.
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