CAPSURE FIX
FDA premarket approval P980016/S325 · decided 2012-04-06
Approval details
- PMA number
- P980016
- Supplement
- S325
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE FIX
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-10-24
- Decision date
- 2012-04-06
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
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