PMA P830060S069
- Device
- TACHY ADAPTER (ACCESSORY)
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S069
- Product code
- LWS
- Decision date
- 2011-06-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
Current openFDA PMA Record#
- Device
- TACHY ADAPTER (ACCESSORY)
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S069
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-06-17
- Decision code
- OK30
- Date received
- 2011-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.