ANCHORING SLEEVE KIT
FDA premarket approval P030036/S022 · decided 2011-05-05
Approval details
- PMA number
- P030036
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANCHORING SLEEVE KIT
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-07-30
- Decision date
- 2011-05-05
- Days to decision
- 279 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN VILLABLA, PUERTO RICO.
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