MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 5033
FDA premarket approval P850089/S051 · decided 2003-05-09
Approval details
- PMA number
- P850089
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 5033
- 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.