IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)
FDA premarket approval P960040/S286 · decided 2013-02-20
Approval details
- PMA number
- P960040
- Supplement
- S286
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-01-22
- Decision date
- 2013-02-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE DESIGNATION OF THE ANODE FOIL CHLORIDE CONTENT SPECIFICATION FROM THE DESIGN SPECIFICATION TO THE PERFORMANCE SPECIFICATION.
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