TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025
FDA premarket approval P860008/S023 · decided 2017-06-19
Approval details
- PMA number
- P860008
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 2017-05-16
- Decision date
- 2017-06-19
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- New supplier for the molding of the pacing wire connector.
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