MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM
FDA premarket approval P900061/S066 · decided 2006-07-12
Approval details
- PMA number
- P900061
- Supplement
- S066
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-06-28
- Decision date
- 2006-07-12
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE PRESCRIPTION LABEL INADVERTENTLY OMITTED FROM THE MANUALS FOR THE MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) AND THE MODEL 5460 ACE HEADER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.