REPLY/ESPRIT SR AND DR MODEL PACEMAKERS
FDA premarket approval P950029/S079 · decided 2013-06-20
Approval details
- PMA number
- P950029
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY/ESPRIT SR AND DR MODEL PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-04-30
- Decision date
- 2013-06-20
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A MODIFICATION TO THE FLEX CIRCUIT HYBRID COMPONENT AND APPRFOR AN ALTERNATE SUPPLIER.
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