TAP SYSTEM 2A
FDA premarket approval P840002/S013 · decided 2016-03-24
Approval details
- PMA number
- P840002
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TAP SYSTEM 2A
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardiocommand, Inc.
- Date received
- 2015-05-28
- Decision date
- 2016-03-24
- Days to decision
- 301 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- Approval for a manufacturing site located at Cardiocommand, Inc., in Tampa, Florida, for the manufacture of the Tapsystem Model 2A device.
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