REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR
FDA premarket approval P950029/S094 · decided 2014-08-27
Approval details
- PMA number
- P950029
- Supplement
- S094
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-08-06
- Decision date
- 2014-08-27
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ALTERNATE THERMOSEALING EQUIPMENT TO PERFORM BLISTER SEALING OPERATION FOR PACEMAKERS AND DEFIBRILLATORS.
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