KAPPA 700
FDA premarket approval P820003/S115 · decided 2012-03-23
Approval details
- PMA number
- P820003
- Supplement
- S115
- Supplement type
- 30-Day Notice
- Trade name
- KAPPA 700
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-29
- Decision date
- 2012-03-23
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.