ORCHESTRA PROGRAMMER
FDA premarket approval P980049/S004 · decided 2001-01-31
Approval details
- PMA number
- P980049
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORCHESTRA PROGRAMMER
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2001-01-16
- Decision date
- 2001-01-31
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A "CAUTION:" LABEL TO BE PLACED ON THE ORCHESTRA PROGRAMMER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.