ELA RATE-RESPONSIVE PACEMAKERS
FDA premarket approval P950029/S011 · decided 2000-10-11
Approval details
- PMA number
- P950029
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELA RATE-RESPONSIVE PACEMAKERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2000-08-18
- Decision date
- 2000-10-11
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL IS FOR THE FOLLOWING MODIFICATIONS TO YOUR BRIO FAMILY OF PACEMAKERS: 1) MODIFY THE VALUE FOR THE NUMBER OF CYCLES THE DEVICE WILL ALLOW BEFORE A SELF TEST IS INITIATED WHEN THE SENSOR "CALLS FOR AN ELEVATED PACING RATE FOR A DURATION OR FREQUENCY THAT EXCEES REASONABLE PHYSIOLOGIC LIMITS" FROM 30,000 TO 100,000 CYCLES; AND2) CHANGING THE MINIMUM SENSING THRESHOLD DURING T-WAVE PROTECTION FROM 2.2 TO 2.5MV.
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