VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER
FDA premarket approval P980049/S022 · decided 2006-03-15
Approval details
- PMA number
- P980049
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-01-17
- Decision date
- 2006-03-15
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.