ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE
FDA premarket approval P900061/S122 · decided 2013-07-23
Approval details
- PMA number
- P900061
- Supplement
- S122
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-05-17
- Decision date
- 2013-07-23
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
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