FRONTIER
FDA premarket approval P030035/S090 · decided 2012-04-13
Approval details
- PMA number
- P030035
- Supplement
- S090
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FRONTIER
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-11-30
- Decision date
- 2012-04-13
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
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