INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS
FDA premarket approval P940008/S016 · decided 2001-04-25
Approval details
- PMA number
- P940008
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS
- Applicant
- Boston Scientific
- Date received
- 2001-03-27
- Decision date
- 2001-04-25
- Days to decision
- 29 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE FOLLOW-UP INDICATORS REFLECTING BATTERY LONGEVITY.
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