REPLY/ESPRIT PACEMAKERS
FDA premarket approval P950029/S072 · decided 2012-12-11
Approval details
- PMA number
- P950029
- Supplement
- S072
- Supplement type
- Real-Time Process
- Trade name
- REPLY/ESPRIT PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2012-10-25
- Decision date
- 2012-12-11
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A CHANGE TO THE QUARTZ CRYSTAL.
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