LEAD ADAPTERS MODEL NUMBER 6024
FDA premarket approval P910073/S047 · decided 2004-09-13
Approval details
- PMA number
- P910073
- Supplement
- S047
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LEAD ADAPTERS MODEL NUMBER 6024
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-08-17
- Decision date
- 2004-09-13
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE SUPPLIER THAT PROVIDES THE MOLD RELEASE COATING THAT IS USED ON THE SLEEVE OF THE LEAD ADAPTERS TO PREVENT THE BONDING OF THE SILICON SLEEVE TO ITSELF.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.