REPLY PACEMAKERS
FDA premarket approval P950029/S032 · decided 2008-07-25
Approval details
- PMA number
- P950029
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2007-11-09
- Decision date
- 2008-07-25
- Days to decision
- 259 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR REPLY SR/DR PACEMAKER MODELS AND SMARTVIEW 2.08UG1 PROGRAMMING SOFTWARE MANUFACTURED BY SORIN BIOMEDICA CRM, S.R.L., SALUGGIA (VC) ITALY.
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