ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM
FDA premarket approval P860008/S022 · decided 2012-07-18
Approval details
- PMA number
- P860008
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 2012-06-18
- Decision date
- 2012-07-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- ADDITION OF A NEW PIECE OF EQUIPMENT USED TO CUT AND STRIP PACING WIRES AND SHRINK TUBING.
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