NON-RATE RESPONSIVE PACEMAKERS
FDA premarket approval P900022/S007 · decided 2006-07-26
Approval details
- PMA number
- P900022
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NON-RATE RESPONSIVE PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-07-11
- Decision date
- 2006-07-26
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.