BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE
FDA premarket approval P950029/S005 · decided 1999-08-25
Approval details
- PMA number
- P950029
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-02-26
- Decision date
- 1999-08-25
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for access to programmable rest-rate and non-invasive physiological stimulation (NIPS) parameters. The device is indicated for dual-chamber cardiac pacing with the ability to perform limited non-invasive electrophysiological studies.
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