VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS
FDA premarket approval P950029/S025 · decided 2006-03-15
Approval details
- PMA number
- P950029
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-01-30
- Decision date
- 2006-03-15
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS.
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