PMA P910077S067
- Device
- MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S067
- Product code
- LWS
- Decision date
- 2006-12-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.
Current openFDA PMA Record#
- Device
- MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S067
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2006-12-06
- Decision code
- OK30
- Date received
- 2006-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.