SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL
FDA premarket approval P030036/S053 · decided 2013-02-28
Approval details
- PMA number
- P030036
- Supplement
- S053
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-01
- Decision date
- 2013-02-28
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR 2 CONTENT CHANGES IN THE SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.