PMA P840002S013
- Device
- TAP SYSTEM 2A
- Applicant
- Cardiocommand, Inc.
- PMA number
- P840002
- Supplement
- S013
- Product code
- LPA
- Decision date
- 2016-03-24
- Classification
- System, Esophageal Pacing
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Approval order statement
- Approval for a manufacturing site located at Cardiocommand, Inc., in Tampa, Florida, for the manufacture of the Tapsystem Model 2A device.
Current openFDA PMA Record#
- Device
- TAP SYSTEM 2A
- Applicant
- Cardiocommand, Inc.
- PMA number
- P840002
- Supplement
- S013
- Product code
- LPA
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Decision date
- 2016-03-24
- Decision code
- APPR
- Date received
- 2015-05-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Cardiocommand, Inc., in Tampa, Florida, for the manufacture of the Tapsystem Model 2A device.