PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
FDA premarket approval P080012/S004 · decided 2013-02-13
Approval details
- PMA number
- P080012
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Infusyn Therapeutics, LLC
- Date received
- 2012-04-20
- Decision date
- 2013-02-13
- Days to decision
- 299 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Hackettstown, NJ
- Statement
- APPROVAL FOR A MODIFICATION TO THE LABELING CLAIM FROM "MR UNSAFE"TO "MR CONDITIONAL" USE.
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