MEDTRONIC MODEL CAPSUREFIX 6940
FDA premarket approval P980016/S032 · decided 2003-05-09
Approval details
- PMA number
- P980016
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL CAPSUREFIX 6940
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-12-24
- Decision date
- 2003-05-09
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
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