REPLY SR AND DR, ESPRIT SR AND DR
FDA premarket approval P950029/S078 · decided 2013-03-26
Approval details
- PMA number
- P950029
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY SR AND DR, ESPRIT SR AND DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-02-25
- Decision date
- 2013-03-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGES TO THE PROCESS LIMITS FOR GASES USED TO FILL FINISHED DEVICES AND ALSO UPDATES TO THE GAS CONCENTRATION LIMITS WITHIN THE INTERNAL ATMOSPHERE FOR THE IMPLANTABLE PULSE GENERATORS.
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