ESOPHAGEAL PACING SYSTEM
FDA premarket approval P860008/S020 · decided 2012-03-06
Approval details
- PMA number
- P860008
- Supplement
- S020
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESOPHAGEAL PACING SYSTEM
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 2011-10-24
- Decision date
- 2012-03-06
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL FOR AUTOMATING THE CNC MILLING PROCESS AND THE ADDITION OF A NEW INSPECTION MOLDING MACHINE.
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