ALTO SHOCK 4 MODULES
FDA premarket approval P980049/S019 · decided 2005-05-13
Approval details
- PMA number
- P980049
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALTO SHOCK 4 MODULES
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2005-04-13
- Decision date
- 2005-05-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGES TO THE MANUFACTURING PROCESS AT INTERNATIONAL RECTIFIER, LEOMINSTER, MASSACHUSETTS AND THALES, NEUILLY-SUR-SEINE, FRANCE. THE MODIFICATIONS INCLUDE: 1) CHANGING THE EPOXY RESIN FOR ENCAPSULATION 2) REMOVING THE PARYLENE COATING 3) CHANGING THE PHOTOCOUPLER AND DISCHARGE CIRCUITS FORM SEPARATE COMPONENTS TO A SINGLE COMPONENT COATED WITH EPOXY 4) CHANGING THE EPOXY FOR ATTACHING THE TRANSFORMER, AND 5) ADDING A SILICONE COVER OVER CERTAIN CAPACITORS PRIOR TO THE FINAL ASSEMBLY PROCESS.
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