MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON...
FDA premarket approval P830061/S035 · decided 2003-05-09
Approval details
- PMA number
- P830061
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON...
- Generic name
- permanent pacemaker Electrode
- 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
- DTB
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.