ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS
FDA premarket approval P030035/S050 · decided 2009-01-16
Approval details
- PMA number
- P030035
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-12-18
- Decision date
- 2009-01-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGES TO THE CLEANING PROCESS USED FOR FEEDTHROUGH AND HYBRID CERAMIC SUBSTRATES AT THE COMPONENT VENDOR.
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