OVAL PATCH LEAD
FDA premarket approval P900061/S109 · decided 2011-12-23
Approval details
- PMA number
- P900061
- Supplement
- S109
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVAL PATCH LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-07-28
- Decision date
- 2011-12-23
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE RELOCATION OF A CONTROLLED ENVIRONMENT AREA (CEA).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.