CAPSURE FIX LEAD
FDA premarket approval P980016/S221 · decided 2010-03-16
Approval details
- PMA number
- P980016
- Supplement
- S221
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE FIX LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-01-15
- Decision date
- 2010-03-16
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.