CADENCE ICDS
FDA premarket approval P910023/S229 · decided 2010-06-28
Approval details
- PMA number
- P910023
- Supplement
- S229
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CADENCE ICDS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-01-25
- Decision date
- 2010-06-28
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER OF AN ELECTRONIC ASSEMBLY MODULE.
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