MEDTRONIC MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT
FDA premarket approval P860004/S068 · decided 2005-03-10
Approval details
- PMA number
- P860004
- Supplement
- S068
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2005-02-07
- Decision date
- 2005-03-10
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A TECHNICAL MANUAL ADDENDUM TO BE ADDED TO THE PACKAGED CATHETER KIT TO STRENGTHEN THE INSTRUCTIONS FOR THE PROPER USE OF THE CONNECTOR.
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