ELA MEDICAL'S REPLY PACEMAKERS
FDA premarket approval P950029/S048 · decided 2010-06-18
Approval details
- PMA number
- P950029
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ELA MEDICAL'S REPLY PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-11-04
- Decision date
- 2010-06-18
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR SOFTWARE VERSIONS W1.5.2 AND W1.5.3 FOR THE REPLY PACEMAKER.
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