EPICARDIAL LEADS AND ACCESSORIES
FDA premarket approval P900061/S103 · decided 2011-06-10
Approval details
- PMA number
- P900061
- Supplement
- S103
- Supplement type
- 30-Day Notice
- Trade name
- EPICARDIAL LEADS AND ACCESSORIES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-13
- Decision date
- 2011-06-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE THE CLEANING AREA OF THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.