PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
FDA premarket approval P910023/S099 · decided 2006-06-26
Approval details
- PMA number
- P910023
- Supplement
- S099
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-02-07
- Decision date
- 2006-06-26
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CHANGES TO THE AUTOMATED TEST SOFTWARE (ATE) USED FOR COMPONENT AND SUBASSEMBLY LEVEL TESTING DURING THE MANUFACTURING PROCESS.
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