CAPSURE(R)SP PACING LEADS
FDA premarket approval P830061/S015 · decided 1991-03-20
Approval details
- PMA number
- P830061
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE(R)SP PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1990-01-07
- Decision date
- 1991-03-20
- Days to decision
- 437 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.