Implantable Cardioverter Defibrillator ICDs
FDA premarket approval P980049/S127 · decided 2018-01-25
Approval details
- PMA number
- P980049
- Supplement
- S127
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Cardioverter Defibrillator ICDs
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-01-03
- Decision date
- 2018-01-25
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Replace the solder mask material, to allow for rework of RF modules on hybrids, and to incorporate use of alternate thermosealing equipment during the packaging process.
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