CAPSURE FIX
FDA premarket approval P980016/S126 · decided 2008-04-18
Approval details
- PMA number
- P980016
- Supplement
- S126
- Supplement type
- 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
- 2008-03-24
- Decision date
- 2008-04-18
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
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