TAPSCOPE 550
FDA premarket approval P860008/S021 · decided 2012-06-05
Approval details
- PMA number
- P860008
- Supplement
- S021
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- TAPSCOPE 550
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 2012-02-29
- Decision date
- 2012-06-05
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL OF A NEW SUPPLIER FOR THE MOLDING OF THE PACING WIRE CONNECTOR AND REVISION TO THE MANUFACTURING PROCESS OF THE PACING WIRE ASSEMBLY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.